|Year : 2021 | Volume
| Issue : 3 | Page : 479-485
Dietary risk factors for colorectal cancer: A hospital-based case–control study
Tasneef Zargar1, Dinesh Kumar1, Bhavna Sahni1, Nadeem Shoket2, Kiran Bala1, Shabab Angurana3
1 Department of Community Medicine, GMC, Jammu, India
2 Department of Medical Oncology, American Oncology Institute, ASCOMS, Jammu, India
3 Department of Radiotherapy, GMC, Jammu, India
|Date of Submission||21-May-2021|
|Date of Decision||08-Jun-2021|
|Date of Acceptance||18-Sep-2021|
|Date of Web Publication||08-Oct-2021|
Department of Radiotherapy, GMC, Jammu, Jammu, Jammu and Kashmir
Source of Support: None, Conflict of Interest: None
Background: Establishing a link between diet and cancer is an epidemiological challenge, and such relationships have not been thoroughly investigated.
Objectives: We aimed to explore the presence of a possible relationship between diet and colorectal cancer.
Material and Methods: This case–control study was conducted at the Government Medical College, Jammu, a regional cancer center in Jammu and Kashmir in North India. We collected the dietary information from 1 year prior to the date of diagnosis for a total of 100 patients with colorectal cancer, 100 hospital controls, and 100 healthy controls. Data were collected by administering the food frequency questionnaire as a part of a personal interview. Data were analyzed using the Chi-squared test, and odds ratios (ORs) were calculated with 95% confidence intervals (CIs).
Results: The risk of colorectal cancer among men who consumed alcohol was greater than that among the healthy controls (OR: 2.6, 95% CI: 1.27–5.31). Similarly, risk was greater among those who consumed hot tea (OR: 1.81, 95% CI: 0.99–3.31). The odds of developing colorectal cancer were 4–19 times higher with the consumption of red meat, while of consumption of fruits, vegetables, wheat and pulses with rice once a day conferred significant protection to participants in both the control groups. Consumption of dairy products and ghee also seemed to confer protection against colorectal cancer, ranging from 39% to 95% and 77% to 85%, respectively. The odds of consumption of pickled foods were significantly higher among those with colorectal cancer as compared to the healthy controls (OR: 2.0–3.63).
Conclusions: The consumption of certain foods and beverages such as alcohol, hot tea, red meat, and pickles is associated with an increased risk of colorectal cancer. Thus, our results suggest that the risk of developing colorectal cancer is associated with dietary habits and that effective prevention is possible.
Keywords: Alcohol, colorectal neoplasms, dairy, diet, dietary fiber, epidemiology, red meat, tea
|How to cite this article:|
Zargar T, Kumar D, Sahni B, Shoket N, Bala K, Angurana S. Dietary risk factors for colorectal cancer: A hospital-based case–control study. Cancer Res Stat Treat 2021;4:479-85
|How to cite this URL:|
Zargar T, Kumar D, Sahni B, Shoket N, Bala K, Angurana S. Dietary risk factors for colorectal cancer: A hospital-based case–control study. Cancer Res Stat Treat [serial online] 2021 [cited 2021 Dec 9];4:479-85. Available from: https://www.crstonline.com/text.asp?2021/4/3/479/327753
| Introduction|| |
Cancer has a complicated etiology, and the risk factors for cancer are ingrained in genetics and environment. Globally, an estimated 19.3 million new cancer cases and approximately 10 million cancer deaths occurred in 2020. Female breast cancer has surpassed lung cancer as the most commonly diagnosed cancer (11.7%), followed by lung (11.4%) and colorectal cancer (10.0%) in the third place. However, lung cancer is still the leading cause of cancer death (18%), followed by colorectal cancer (9.4%). Overall, cancer is the sixth leading cause of death worldwide.
Studies have shown that approximately a third of all cancer deaths in the United States of America may be preventable by dietary modifications. Dietary factors play a role at various intermediary steps in the pathways that influence the risk of developing cancer, for example, the frequency of cell division and growth, DNA repair, methylation, and apoptosis. It is known that mutagens produced by heating dietary proteins can damage the DNA; however, it is also known that some dietary factors may play a protective role against DNA damage by inactivating or blocking the action of the mutagens or enzymes that activate the mutagens. There is strong evidence that being physically active and consuming whole grains, foods containing fiber, dairy products, and calcium supplements decreases the risk, while consuming red meat, processed meat, alcoholic drinks, and being overweight, obese, or tall can increase the risk of developing colorectal cancer.
Different methodologies have been adopted to understand the association of dietary patterns with the occurrence of cancer in various populations. However, there are inherent problems with most study designs, as majority are prone to confounding biases and measurement errors. Moreover, dietary and cooking practices vary widely from region to region. Thus, quantification of diet is challenging as it is difficult to estimate the type and amount of nutrients contained in a portion.
Various dietary measurement tools can be used for assessing the association of diet with cancer. However, the choice of instrument depends on what is being assessed, the habitual intake, or the type of food consumed immediately prior to the study. For assessing the habitual intake, as in the present study, food frequency questionnaires are commonly employed.
Although the relationship between diet and cancer is interesting and has been frequently studied, the majority of the evidence generated is inconsistent. However, in India, the association between diet and cancer has been negligibly investigated due to problems associated with the measurement of diet as exposure, long latent period between exposure and development of cancer, and the complex natural history of cancer.
In this study, we aimed to understand the relationship between diet and colorectal cancers. We also aimed to collect information about the constituents of the local diet, like pickles, which have been minimally investigated earlier.
| Material and Methods|| |
General study details
This case–control study was conducted in the Department of Radiotherapy (Regional Cancer Center) of the Government Medical College, a tertiary care teaching hospital in Jammu in North India. Study participants were selected from among the patients registered in the hospital-based cancer registry (HBCR) from November 1, 2018, to October 31, 2020. The HBCR is functional since 2014 and is jointly run by the Department of Radiotherapy and the Postgraduate Department of Community Medicine under the Indian Council of Medical Research (NCDIR-ICMR). The study was approved by the Institutional Ethical Committee (vide letter No. IEC/Pharma/Thesis/Research/2018/593 dated October 26, 2018) [Supplementary Appendix 1]. The study was conducted according to the ethical guidelines outlined in the Declaration of Helsinki, Good Clinical Practice guidelines, and ICMR guidelines. Verbal informed consent was obtained from all the participants after briefing them about the purpose of the study in a language they could understand.
The criteria for the inclusion in the study included patients who were newly diagnosed with histopathologically confirmed colorectal cancer, aged >18 years, had resided in Jammu and Kashmir for at least 10 years, provided consent for participation, and were willing for follow-up. We excluded patients who were seriously ill, bed-ridden, not able to communicate, or had cognitive impairment. In addition, those who had previously received any form of cancer-directed treatment and those with familial colorectal cancer syndromes such as adenomatous polyposis coli or hereditary nonpolyposis colon cancer (Lynch syndrome) and Peutz-Jegher syndrome were excluded.
The study comprised two control groups, namely hospital controls and healthy controls. Participants in the control groups were sex- and age-matched (±5 years) with the cases. The hospital control group included female patients with cervical cancer and male patients with head and neck cancers registered in the HBCR over the past 1–2 years. The healthy control group comprised participants who were siblings, friends, neighbors, or healthy attendants of other patients. All other eligibility criteria (except for the criteria specific to colorectal cancers) were the same as those for the case group.
The relationship between diet and colorectal cancer was assessed by comparing the dietary pattern of cases with that of the controls. The consumption of different foods and beverages such as alcohol, hot tea, red meat, fruits, green and non-green leafy vegetables, dairy products, ghee, wheat, rice, pulses, and pickled foods was recorded.
The following basic information was collected from the participants and filled into the core pro forma of HBCR: identifying information, basic demographic parameters, diagnosis clinical stage, and treatment.
Thereafter, a food frequency questionnaire was administered to the participants during a personal interview to collect information related to their dietary patterns. The food frequency questionnaire used in the present study was designed based on the work done by Telles et al. and Sudha et al., Minor modifications were made to the food frequency questionnaires from the above studies by piloting them on the local population. Items such as idli, dosa, drumstick, parval, jaggery, and sweet kadhi, which are less frequently consumed in Jammu and Kashmir, were substituted with tea without milk, desi chai (red tea), maize, barley, lotus root, kohl rabi greens, Indian gooseberry, beef, pork, walnut/anardana chutneys, spices, etc. The food frequency questionnaire consisted of 123 food items and took about 20–30 min to complete. All participants responded to the food frequency questionnaire based on their dietary patterns from 1 year prior to the diagnosis of cancer. A similar time limit was used for participants in the control groups. Apart from the dietary pattern, the frequency and portion size were assessed using standardized utensils. Only those food items that were consumed more than once a week and in moderate to high quantities were included in the analysis.
All data obtained from both cases and controls were entered into Microsoft Excel and analyzed using the Statistical Package for the Social Sciences (SPSS) version 21 (IBM Corp. Armonk, NY, USA) and OpenEpi toolkit Version 3.01 (Dean AG, Sullivan KM, Soe MM. OpenEpi: Open Source Epidemiologic Statistics for Public Health, Version. www.OpenEpi.com, updated 2013/04/06, accessed 2021/09/17), after performing the necessary checks for correctness of the data. Dietary pattern was represented as proportions of cases and controls consuming different food groups of interest. The strength of association between diet and colorectal cancer was assessed by calculating the odds ratios (OR) with their corresponding 95% confidence intervals (CIs). The following formula was used to calculate the 95% CI:
Upper 95% CI = e ^ [ln (OR) +1.96 sqrt (1/a + 1/b + 1/c + 1/d)]
Lower 95% CI = e ^ [ln (OR) −1.96 sqrt (1/a + 1/b + 1/c + 1/d)]; where “e” is the mathematical constant for the natural log, “ln” is the natural log, “OR” is the odds ratio calculated, “sqrt” is the square root function and a, b, c, and d are the values from the respective 2 × 2 table.
The relationship of each food item with colorectal cancer was analyzed using the Chi-squared test. P <0.05 was considered statistically significant, and all P values used were two-tailed.
| Results|| |
A total of 100 patients with colorectal cancers registered in the HBCR between November 1, 2018, and October 31, 2020, were included in the study, after taking into account deaths, migration, and refusal to participate in the study. In addition, 100 participants each were included in the hospital and healthy control groups [Figure 1].
|Figure 1: Flow chart showing selection of colorectal cancer cases and hospital controls. *2nd group of controls was chosen in 1:1 ratio from a pool of accompanying attendants, neighborhood and family members. Number chosen up to the pre-decided period to attain 1:1 ratio with male and female patients with colorectal cancer|
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The mean age of the participants was 53.5 years (range 19–85), and about two-thirds of the participants were male [Table 1]. The most common site of the primary tumor was the colon (54%), followed by the rectum (40%) and rectosigmoid (6%). The most common histology was adenocarcinoma (79%), followed by mucinous carcinoma (16%), squamous cell carcinoma (3%), and signet ring carcinoma (2%). According to the tumor, node, and metastasis staging system, 42% of patients had Stage-III, 35% had Stage-IV, 17% had Stage-II, and 6% had Stage-I disease.
In all the groups, the proportion of participants living in the rural areas was slightly greater than that of those living in the urban areas. About 84% of the participants in the hospital control group were Hindus, whereas nearly a third of the participants in the healthy control group were Muslims. The majority of the participants were married; in the case group, the proportions of patients who reported sedentary, moderately active, and highly active work were roughly equal, whereas in the control groups, a greater proportion of participants reported moderately active work.
[Table 2] shows that the odds of developing colorectal cancers among men increased by almost three times with the consumption of alcohol. Similarly, the odds of developing colorectal cancer increased by 1.81 times with the consumption of hot tea and 4–19 times with the consumption of red meat; the relationship was statistically significant. Contrarily, we observed that the consumption of fruits and vegetables conferred significant protection against colorectal cancers. In addition, the consumption of dairy products and ghee also seemed to confer protection against colorectal cancer, which ranged from 39% to 95% and from 77% to 85% in cases of dairy and ghee, when cases were compared with healthy and hospital controls. The consumption of wheat and pulses with rice once a day also conferred protection against colorectal cancer. Interestingly, the consumption of pickled food was observed to be higher among cases as compared to the controls and was found to be associated with increased odds of developing colorectal cancer.
|Table 2: Consumption of various foods and beverages by the participants over the past 1 year|
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| Discussion|| |
Upon investigating the relationship between alcohol and colorectal cancer, we observed that male patients with colorectal cancer showed greater odds of alcohol consumption compared to healthy controls. However, the same was not true for hospital controls. This could be because the hospital control group comprised a greater proportion of men with head and neck cancers and most of them consumed alcohol.
We observed an inverse relationship between the consumption of foods rich in dietary fiber, such as cereals (wheat, pulses, and rice), fruits, and vegetables (cooked and raw vegetables) and colorectal cancer which is in concordance with the findings of previous epidemiological studies.,,,,, However, a study from Southeast Siberia showed no association between the consumption of fruits and vegetables and the risk of developing colorectal cancer. The mechanisms by which dietary fiber confers protection have been delineated in several studies; dietary fiber has been shown to shorten the transit time and the starch and oligosaccharides in dietary fiber also limit the ability of bile acids to act as carcinogens. In case of fruits, the protective role against cancer has been attributed to selenium, folic acid, carotenoids, and other flavonoids.
The positive and significant association of red meat consumption with colorectal cancer observed in the current study has also been reported in other previous studies.,,,,,, Contrarily, there are some studies that report the lack of evidence to support these findings., Several mechanisms have been put forward to explain the association between red meat consumption and colorectal cancer. Cooking of meat produces carcinogens such as polycyclic aromatic hydrocarbons, heterocyclic amines, and nitrate and nitroso compounds, which facilitate the development of colorectal cancer. Red meat contains high levels of heme iron, which promotes colorectal tumorigenesis by stimulating the formation of carcinogenic N-nitroso compounds. Processed meat rich in fat and heme iron also promotes tumorigenesis via the mechanism described above.
Conflicting reports are available regarding the role of dietary products on the occurrence of colorectal cancers.,,, Our findings are in tune with previous reports that suggest that dairy products can reduce the risk of colon cancer due to their high calcium content; calcium has the ability to bind unconjugated bile acids and free fatty acids thereby decreasing their toxic effects on the colon and rectum. Thus, modifications in dietary habits can help reduce the risk of colorectal cancer. For instance, an increased consumption of low-fat dairy products, fruits, vegetables, and whole grains can confer protection against colorectal cancer, whereas a reduction in the consumption of alcohol, tobacco, and red and processed meat can lower the likelihood of developing colorectal cancer.
The strengths of our study include the use of a food frequency questionnaire specific to the Indian diet, a large sample size, and the use of two control groups for comparative analysis. Moreover, ours is the first study to assess the association between diet and colorectal cancer in this region of the country.
In future, to further elucidate the relationship between diet and colorectal cancers, we aim to update the tools used in this study and plan to conduct more cohort studies under the ambit of the HBCR Project. We also intend to use the data generated from this study to educate the local population by organizing activities to disseminate information at the community level, regarding the protective and harmful effects of various foods in our daily diet, in order to encourage positive dietary changes. We also aim to share our understanding with other stakeholders in the state for policy planning in the context of expansion of Cancer Control activities in Jammu and Kashmir.
The study was not without limitations. Evidence suggests that dietary reporting methods such as food frequency questionnaires tend to overestimate the usual intake and may substantially attenuate risk assessment. Often, information about similar foods is clubbed together, thus making it cognitively difficult for participants to report the relative frequency of consumption of a particular food. The length of the food frequency questionnaire, seasonality, portion size, and recall bias may also have affected the validity of the responses to the questionnaire. Our study investigated the dietary patterns only in the one year preceding the diagnosis of cancer. However, it is known that the development of cancer occurs over a period of several years. Finally, because of resource constraints, the findings from our study could not be validated in a larger cohort, thus allowing for the possibility of inaccurate assessment of exposure, which might have led to the misclassification and consequently attenuation of the strength of association in case of certain foods.
| Conclusions|| |
Our results suggest that the risk of developing colorectal cancer is associated with dietary habits and that effective prevention is possible. We found that the consumption of certain foods and beverages such as alcohol, hot tea, red meat, and pickles is associated with an increased risk of colorectal cancer.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| Supplementary Appendix|| |
Supplementary Appendix 1: Study protocol
Cancer word origin is credited to the Greek physician Hippocrates (460-370 BC), the “Father of Medicine”. Terms carcinos and carcinoma were used by Hippocrates to describe nonulcer forming and ulcer-forming tumors. In Greek, these words refer to a crab, to resemble the shape of a crab because of the finger-like spreading projections from a cancer. The Roman physician, Celsus (28-50 BC), later translated the Greek term into cancer, the Latin word for crab. Galen (130-200 AD), another Greek physician, used the word oncos (Greek for swelling) to describe tumors (The American Cancer Society. Last revised 2018). Essentially all of the increase in cancer rates between prehistoric times and people who died in England between 1901 and 1905 is due to increased lifespans (Johnson, George 2010, The New York Times). Notwithstanding the above, it is intuitive that if we could decrease the cumulative exposure to putative causes of cancer, the risk with age would definitely decrease. This is substantiated by the fact that 50%–60% of the causes of cancers worldwide are preventable in nature (WHO FACT SHEET 2018). Doll and Peto speculated that 35% (range: 10%–70%) of all cancer deaths in the United States may be preventable by alterations in diet. Doll and Peto made their estimates by cancer site, indicating that perhaps 90% of stomach and colorectal cancers; 50% of endometrium, gallbladder, pancreas, and breast cancers; 20% of lung, bladder, and cervix cancers; and 10% of other cancers may be diet related (Doll and Peto 1981). The incriminating factors included in diet are of high salt intake, consumption of red meat, processed meat, etc. (Vingeliene S Ann oncol. 2017). Apart from diet, other modifiable risk factors include tobacco smoking, alcohol drinking, diet low in fruits and vegetables, physical inactivity, obesity, human papillomavirus, exposure to ionizing and UV radiations, and occupational exposure (World Cancer Research Fund International Continuous Update Project: 2017; available from wcrf.org/cupmatrix). However, the magnitude of the estimate for dietary factors exceeded that for tobacco (30%) and infections (10%) and physical inactivity (7%) (Doll and Peto 1981).
Cancer is the sixth leading cause of death worldwide (WHO FACT SHEET 2018). Lung cancer is the most common cancer worldwide (Globocan 2012 V 1.1). Colorectal (bowel) cancer is the third most common, stomach cancer is the fifth most common, and esophageal cancer is eighth most common cancer worldwide (Vingeliene Ann Oncol. 2017). However, in India, breast cancer is the most common cancer while stomach cancer is the leading cause of death by cancer for the population as a whole (Globocan 2012 V 1.1). While breast cancer and lung cancer kill the most women and men respectively (The Hindu, 2015-05-29. ISSN 0971-751X. Retrieved 2016-02-27).
There were 14.1 million new cancer cases, 8.2 million cancer deaths, and 32.6 million people living with cancer (within 5 years of diagnosis) in 2012 worldwide (Ferlay et al., Globocan 2012 v1.0) (Bray, et al. 2018). In India, an estimated number of people living with the cancer are around 2.5 million. Every year, over 7 lakh new cancer patients are registered and cancer related deaths are 5.5 lakhs (Nandakumar, 2009). As is pertinent to the current study, about 1.4 million new cases of colorectal cancer, around 9.5 lakh new cases of stomach cancer, and 4.5 lakh new cases of esophageal cancer were recorded globally in 2012, accounting for 10%, 7% and 3.2% of all new cases of cancer, respectively (Vingeliene, et al. Ann Oncol. 2017).
According to the National Cancer Registry of the India Council of Medical Research (ICMR), more than 1300 Indians die every day due to cancer. Between 2012 and 2014, mortality rate due to cancer increased by approximately 6%. In 2012, there were 478,180 deaths out of 2934,314 cases reported. In 2013, there were 465,169 deaths out of 3016,628 cases. In 2014, 491,598 people died out of 2820,179 cases (Delhi Daily News. Retrieved 2015-05-17).
As per the Population Cancer Registry of Indian Council of Medical Research, the incidence and mortality of cancer is highest in the north eastern region of the country (National Cancer Registry Programme, 2013). In Jammu region, hospital-based cancer registry is being done at Regional Cancer Center at GMC, Jammu. Around 1930 cancer registries have been done in the year 2017, among which 7.6% were 0 esophageal cancers, 1.9% stomach cancers, 5% lower GI cancers.
Diet may influence the development of cancer through many different mechanisms and at different stages in the cancer process. Dietary factors can affect every pathway hypothesized to mediate cancer risk, for example, the rate of cell cycling through hormonal or antihormonal effects, aiding or inhibiting DNA repair, promoting or inhibiting apoptosis, and DNA methylation. Simple mutagens in foods, such as those produced by the heating of proteins, can cause damage to DNA, but dietary factors can also influence this process by inducing enzymes that activate or inactivate these mutagens, or by blocking the action of the mutagen (DeVita's, Principles and Practice of Oncology 10th Edition. Chapter 9).
Regarding the relationship of diet and gastrointestinal cancers, for esophageal cancers, there is strong evidence that being overweight or obese increases the risk of adenocarcinoma while consuming alcoholic drinks and mate (drunk in the traditional style in South America) increases the risk of esophageal squamous cell carcinoma. The pathogenesis for the same is because of repeated exposure and burns from very high-temperature drinks consumption (mate at high temperature, i.e. over 65°Cincreases nitrosamine induced tumors). For stomach cancer strongest evidence holds true for consuming alcoholic drinks, salt-preserved foods and being overweight or obese leading to increased risk. High salt intake increases the formation of n-nitrosamine compounds. For colorectal cancer, there is strong evidence that being physically active, consuming whole grains, consuming foods containing dietary fiber, consuming dairy products, and taking calcium supplements decreases the risk while consuming red meat, consuming processed meat, consuming alcoholic drinks, being overweight or obese, being tall increases the risk. Dairy products reduce risk of colon cancer due to high calcium content, which has the ability to bind unconjugated bile acids and free fatty acids, thereby decreasing their toxic effects on colorectum. Red meat cooked at high temperature and prolonged heat exposure and cooking by grilling produce heterocyclic aromatic hydrocarbons and heterocyclic amines both of which are linked to colon cancer. Red meat also contains high level of hem iron promoting colorectal tumorigenesis by stimulating formation of carcinogenic N-nitroso compounds. Processed meat rich in fat and hem iron stimulates tumorigenesis through the same mechanism as described above (Vingeliene, et al. Ann Oncol. 2017).
Different methodologies have been adopted to study the association of dietary pattern and the occurrence of cancer in different populations. Common designs used are the case-control study, the cohort study, and the randomized clinical trial. Many ecologic studies have indicated correlation between patterns of dietary intake and occurrence of cancers both within the countries and among migrated populations and even within the countries or states over periods of time. These relationships are subject to ecological fallacy and many such associations have been found to be fallacious at individual level. A linear association may provide preliminary data to inform future research but, problem of high confounding cannot provide strong evidence for a causal link. Prospective cohort studies of the effects of diet can be considered to have a much higher validity than retrospective case control studies because diet is recorded by participants before disease occurrence. There are inherent problems with these study designs as far as investigation of diet and cancers is concerned and both designs that is case–control and cohort are prone to confounding bias and measurement error. Cohort studies are still affected by measurement error because diet consists of a large number of foods eaten in complex combinations. Confounding by other unmeasured or imperfectly measured lifestyle factors can also remain a problem in cohort studies. However, the gold standard in medical research is the randomized clinical trial (RCT). In an RCT on nutrition, participants are randomly assigned to one of two or more diets; hence, the association between diet and the cancer of interest should not be confounded by other factors. The problem with RCTs of diet is maintaining the assigned diet strictly over many years, as would be necessary for diet to have an impact on cancer incidence, is difficult (DeVita's, Principles and Practice of Oncology 10th Edition. Chapter 9.)
Accurate measurement of diet, as exposure, is riddled with difficulties because of the fact that there are many individual constituents of diet which cannot be measured with any precision. How these constituents interact with each other and over a period of time is still unclear. The various dietary instruments which are used for the assessment of diet with cancer are imprecise to say the least. Most frequently used tools are food frequency questionnaire (FFQ), dietary history, healthy eating index, food diaries, 24-h dietary recall, duplicate dietary approach, food consumption record, dietary record, and short dietary assessment methods (Lucchiari et al. 2012) (Thompson and Byers, 1994). The choice of the instrument is dependent on whether we are interested in habitual intake or routine eating pattern or capturing exactly what they consumed immediately prior to the study. For the latter, diet record or 24 h dietary recall method is appropriate. For habitual intake, FFQs are very commonly employed, and for prospective studies, we can use any dietary assessment method (Thompson and Byers, 1994).
FFQs have been widely used since 1990s. Recently, FFQs have been developed using dietary data collection by the open end surveys, then informative foods are selected among the various foods consumed by the subjects and the selected foods are grouped by their nutritional contents or cooking methods and finally presented in a closed ended format. There are two types of FFQS, (1) food-based FFQ and (2) dish-based FFQ. Food-based FFQs tend to underestimate dietary intake more than the dish based FFQs because various seasonings (e.g. salt, red pepper paste) and cooking oils which contribute heavily to the nutrient intake are not considered in dietary intake calculation. Dish-based approach is better for countries where many mixed dishes are cooked with individual ingredients such as seasoning and cooking oils, e.g. Asian countries. FFQs have shown modest correlation (coefficients ranging from 0.5 to 0.7), with more precise methods of estimation of diet such as multiple 24 h dietary recall method and automated multiple pass method (Shim et al., 2014).
FFQ allows measurement of frequency and portion size of food item (Lucchiari et al. 2012). Most FFQs takes about 1 h to complete. It is easy and cheap to administer, captures habitual intake, does not interfere with eating behavior, and allows for the presentation of pictures of foods for ease in reporting portions sizes but for recall error and inappropriate estimation of average frequency and portion size (Thompson and Byers, 1994).
Considering the burden of cancers in terms of DALY's and economic loss, the need of the hour is to focus on prevention. Moreover, treatment of cancer is also associated with poor quality of life. As dietary pattern and culture vary extensively in our country such studies are imperative. Relationship between diet and cancer has been assessed largely in developed part of the world and most of the evidence generated is inconsistent except for the few dietary constituents mentioned above. Very few studies of this nature have been conducted across India. Even within the hospital and population-based registry network such relationships have only been minimally investigated for reasons detailed above e.g. problems with measurement of diet as exposure, long latent period between diet and development of cancers and complex natural history of the disease itself. We intend to undertake a hospital-based case control study aimed at investigating the relationship between diet and cancers. Through this study we intend to inform not only about the relationship between diet and cancers but also collect information about constituents of diet which have not been investigated earlier like spices and condiments. Further, it could help us in refining FFQs to be used for further research. Furthermore, we intent to incorporate investigation of diet related exposures into the core information which is collected under HBCR particularly for cancers which are diet related. Such information would also allow us to mount prospective cohort studies in the future by building in more accurate methods of dietary assessment such as multiple 24 h dietary recall.
- Dales et al. 1978 conducted a case control study of relationship of diet and other traits to colorectal cancer in American blacks. Ninety-nine black colorectal cancer patients and 280 matched controls from hospitals and multiphasic health checkup clinics were interviewed about past dietary habits and other traits. The colon cancer cases tended to report less frequent use of foods with at least 0.5% fiber content than did their controls. This relationship though small, showed a consistent dose-response gradient relationship. Colon and rectosigmoid Junction cancer patients tended to have eaten foods with at least 5% saturated fat somewhat more often than controls. Statistically significant excesses of the following traits were also reported by the colorectal cancer patient: Prolonged cigar smoking In men, nulliparity in women, and history of colorectal polyps
- Trichopoulos et al. 1985 conducted a case control study to focus the role of diet in stomach cancer in Piraeus, Greece included 110 cases of histologically confirmed adenocarcinoma of stomach cancer and 100 controls with orthopedics disorders. Cases reported significantly less frequent consumption of lemons, oranges, brown bread, and raw salad-type vegetables (particularly lettuce, onions and cucumbers) and, independently, significantly more frequent consumption of pasta, beans and nuts. A highly significant negative trend is evident with respect to group containing vegetables, whereas significant positive trends are noted with respect to two groups both of which include starchy food items
- Willett et al. 1990 conducted a prospective study among women to evaluate the relation of meat, fat, and fiber intake to the risk of colon cancer. After adjustment for total energy intake, animal fat was positively associated with the risk of colon cancer (P for trend = 0.01). The relative risk (RR) of colon cancer in women who ate beef, pork, or lamb as a main dish every day was 2.49, as compared with those reporting consumption less than once a month. These prospective data provide evidence for the hypothesis that a high intake of animal fat increases the risk of colon cancer, and they support existing recommendations to substitute fish and chicken for meats high in fat
- De Stefani et al. 1990 conducted a case control study in Uruguay to investigate the role of mate drinking, alcohol, tobacco smoking, dietary factors in esophageal cancer. Study included 261 cases and 522 hospital controls. The RR for those who drink and smoke heavily (over 250 ml of alcohol per day and over 25 cigarettes per day) was 22.6. In relation to alcohol, the risk increases more with the amount of alcohol consumed than with the number of cigarettes smoked. A strong association with a clear dose response relationship was observed with the amount of mate drunk daily and duration of the habit. The RR for those drinking over 2.5 liters of mate per day was 12.2 after adjusting for the confounders. A significant dose response relationship was present for fruits
- Boeing et al. 1991 conducted a case control study in Germany to study relation of diet with stomach cancer included 143 patients with incident stomach cancer and 579 controls. After adjustment for other food constituents, food groups showing inverse relationship were increased consumption of fruit, citrus fruit, cheese and whole-meal bread, Vitamin C and raw vegetables. Increased consumption of processed meat showed a positive association
- Cheng et al. 1992 conducted a case control study in Hong Chong Chinese with 400 cases and 1598 controls (800 hospital and 798 general practice). This is the first case control study to show an association between pickled vegetables and esophageal cancer with a strong effect of attributable risk of about 30%. In multivariate analysis, statistically significant effects included preference for consuming drinks or soups at high temperature (15%), infrequent consumption of citrus fruits and green leafy vegetables (AR = 15%), tobacco smoking (AR = 44%), alcohol drinking (AR = 48%)
- Ramón et al. 1993 conducted a case control study in Spain titled as Dietary Factors and Gastric Cancer Risk. Gastric cancer risk rose with increasing intake of smoked and pickled foods (confidence interval [OR] 3.67 for upper tertile) and salt (OR 2.11 for upper quartile). Intake of citrus fruits (OR 0.47 for upper tertile) and raw-green vegetables (OR 0.56 for upper quartile) appeared to be protective. Gastric cancer risk was not associated with intake of cereals, rice, total vegetables, and fruits as a whole
- Skog et al. 1995 conducted a study in Stockholm Sweden titled as effect of cooking temperature on the formation of heterocyclic amines in fried meat products and pan residues. The intake of meat of the population of Stockholm were fried at four temperatures (150°C, 175°C, 200°C, and 225°C) representing normal household cooking practices in Stockholm. The heterocyclic amines 2-amino-3-methylimidazo [4,5-/]quinolone (IQ), 2-amino-3,8-dimethylimidazo [4,5-/]quinoxaline (MelQx), 2-anuno-3,43-trimethyumidazo[4^-/]quinoxaline (DiMelQx) and 2-amino-l-methyl-6-phenylimidazo [4,5-*]-pyridine (PhIP) were recovered. The highest levels of MelQx were 23.7 ng/g in the meat and 233 ng/g in the pan residue. Corresponding data for DiMelQx were 2.7 and 4.1 ng/g and for PhIP 12.7 and 82.4 ng/g
- Lee et al. 1995 conducted a case-control study in Korea to evaluate the relationship of dietary factors and stomach cancer an increased risk of stomach cancer was noted among those with high consumption of stewed foods such as oybean paste stew and hot pepper-soybean stew, broiled fish, and salty food. However, mung bean pancake, tofu (soybean curd), cabbage, spinach, and sesame oil decreased the risk of stomach cancer. Analysis of cooking methods showed that broiling and salting increased the risk of stomach cancer, but that frying tended to decrease the risk. As nondietary factors, smoking and a family history of stomach cancer increased the risk, but use of a refrigerator decreased the risk of cancer
- Ward et al. 1997 conducted a case control study titled risk of adenocarcinoma of the stomach and esophagus with meat, cooking method and doneness preference included stomach (n = 5176) and esophagus (n = 5143) cancers and 502 controls. High intake of red meat was associated with increased risks for both stomach and esophageal cancers. Barbecuing/grilling, reported as the usual cooking method for a small number of study participants, was associated with an elevated risk of stomach and esophageal cancers. A significant positive trend were evaluated for doneness level
- Launoy et al. 1998 conducted a study called, A FRENCH MULTICENTRE CASE-CONTROL STUDY to find the relation of DIET AND SQUAMOUS-CELL CANCER OF THE OESOPHAGUS: Two hundred eight cases and 399 controls were taken. After proper adjustment for drinking and smoking, high consumption of butter and low consumption of fresh fish, vegetables and fruits were associated strongly and independently with an increase in esophageal-cancer risk. The protective effect of citrus and other fresh fruits (Vitamin C) was confined strictly to heavy drinkers
- Ji, 1998 conducted a casecontrol study to evaluate the relation of DIETARY HABITS AND STOMACH CANCER IN SHANGHAI, CHINA included 1,124 stomach cancer and 1451 controls. Risks of stomach cancer were inversely associated with high consumption of several food groups, including fresh vegetables and fruits, poultry, eggs, plant oil and some nutrients such as protein, fat, fiber and antioxidant vitamins. By contrast, risks increased with increasing consumption of dietary carbohydrates, frequent intake of noodles and bread, preserved, salty or fried foods, and hot soup/porridge, and with irregular meals, speed eating and binge eating
- Levi et al. 2001 conducted a case control study in Switzerland for the relationship between various types of fibers and colorectal cancer included 286 cases of incident, histologically-confirmed colorectal cancers and 550 controls whose admission diagnosis was of acute, nonneoplastic diseases. There was a significant inverse relationship of total fiber intake and of its components with the risk of colorectal cancer. ORs for a difference in intake of one standard deviation from the mean fiber intake of the control distribution was 0.57 for total fibers, 0.55 for soluble noncellulose polysaccharides (NCPs), 0.58 for total insoluble fibers, 0.57 for cellulose, 0.62 for insoluble NCP, and 0.62 for lignin. When fiber was classified according to its source, the OR was 0.60 for vegetables, 0.78 for fruit, and 0.74 for grain fiber
- Ngoan et al. 2002 conducted a cohort study in Japan to find the relationship between stomach cancer and low intake of fresh fruits and vegetables, a high intake of pickled, preserved or salted foods and frequent use of cooking oil with 13250 participant and during 139390 person years of follow-up, 116 subjects died from stomach cancer with different histological types. Using a Cox proportional hazards– regression analysis of RR (95% CI) controlling for confounders, a significant decline was found with a high consumption of green and yellow vegetables (RR = 0.4). The risk was significantly increased by the high consumption of processed meat (RR = 2.7) and by the frequent use of cooking oil (RR = 4.0).
- Nouraie et al. 2005 conducted a prospective cohort study for fruits, vegetables, and antioxidants and risk of gastric cancer among male smokers. During a median follow-up of 12 years, 243 incident gastric adenocarcinomas (64 GCC and 179 GNCC) were diagnosed in this cohort. For GCC (gastric cardiac cancer), high dietary intake of retinol was protective, but high intake of tocopherol increased risk. For GNCC (gastric non cardiac cancer), higher intakes of fruits, Vitamin C, A, tocopherol, and lycopene were protective
- Chao et al. 2005 conducted a cohort study to evaluate meat consumption and risk of colorectal cancer. The study was done to examine the relationship between recent and long-term meat consumption and the risk of incident colon and rectal cancer. High intake of red and processed meat was associated with higher risk of colon cancer. High consumption of red meat was associated with higher risk of rectal cancer (RR, 1.71). Long-term consumption of processed meat (RR, 1.50) had higher risk of distal colon cancer. Long-term consumption of poultry and fish was inversely associated with risk of both proximal and distal colon cancer
- Brink, et al. 2005 conducted a cohort study to evaluate meat consumption and K-ras mutations in sporadic colon and rectal cancer in The Netherland. This study is based on data of gene mutation analysis from CRC patients. Tumor material from 737 incident colorectal adenocarcinoma cases was available. Incidence rate ratios (RRs) and corresponding 95% confidence intervals (CIs) were estimated for colon and rectal cancer cases with wild-type or mutated K-ras gene tumors. Most types of fresh meat and fish were not associated with colon or rectal cancer, neither overall nor with K-ras mutation status. However, several weak associations were observed for tumors with a wild-type K-ras, including beef and colon tumors, and an inverse association for pork with colon and rectal tumors
- Larsson et al. 2006 in his study titled meat consumption and risk of colorectal cancer: A meta-analysis of prospective studies. They identified 15 prospective studies on red meat (involving 7367 cases) and 14 prospective studies on processed meat consumption (7903 cases). The RRs were 1.28 for an increase of 120 g/day of red meat and 1.09 for an increase of 30 g/day of processed meat. Consumption of red meat and processed meat was positively associated with risk of both colon and rectal cancer, although the association with red meat appeared to be stronger for rectal cancer. In 3 studies that reported results for subsites in the colon, high consumption of processed meat was associated with an increased risk of distal colon cancer but not of proximal colon cancer
- Martínez et al. 2007 conducted a study titled meat intake, preparation methods, mutagens, and colorectal adenoma recurrence. Recurrence of advanced or multiple adenomas was more strongly associated with a number of the meat exposure variables evaluated. For recurrence of advanced lesions, significant associations were detected among individuals for pan-fried red meat and well/very well done red meat. Significant positive associations were shown for recurrence of multiple adenomas and the following variables: processed meat, pan-fried red meat, well/and well/very well done red Freedman et al. 2007 conducted a cohort study titled Fruit and vegetable intake and esophageal cancer. During 2,193,751 person years of follow-up, 103 participants were diagnosed with esophageal squamous cell cancer (ESCC) and 213 participants with EAC. A significant inverse association between total fruit and vegetable intake and ESCC risk (HR: 0.78), but not Esophageal adenocarcinoma (EAC). In models mutually adjusted for fruit and vegetable intake, the protective association with ESCC was stronger for fruits than for vegetables. Significant protective associations for ESCC and apples, peaches, nectarines, plums, pears, strawberries and citrus fruits and a significant inverse association between EAC and (spinach) intake was observed.
- Sun-Il Lee et al. 2007 conducted a study titled relationship between meat and cereal consumption and colorectal cancer in Korea and Japan. The data of meat and cereal consumption in Japan (1950–2002) and Korea (1970–2003), and the data of colorectal cancer incidence in Japan (1975–1998) and Korea (1992–2002) were investigated with a 20-year difference between the two countries. It was found that the changes in meat and cereal consumption, as well as the increases in the incidence of colon and rectal cancer, were similar between those two countries with a 20-year difference. These similarities between Korea and Japan could be helpful for predicting future colorectal cancer incidences for Korea and other Asian countries
- Freedman et al. 2007 conducted a cohort study titled Fruit and vegetable intake and esophageal cancer. During 2,193,751 person years of follow-up, 103 participants were diagnosed with ESCC and 213 participants with EAC. A significant inverse association between total fruit and vegetable intake and ESCC risk (HR: 0.78), but not EAC. In models mutually adjusted for fruit and vegetable intake, the protective association with ESCC was stronger for fruits than for vegetables. Significant protective associations for ESCC and apples, peaches, nectarines, plums, pears, strawberries and citrus fruits and a significant inverse association between EAC and (spinach) intake was observed
- Yamaji et al., 2008 conducted a prospective study about fruits and vegetable consumption and squamous cell carcinoma of the esophagus in Japan. During 297,651 person–years of follow-up, a total of 116 men were newly diagnosed with esophageal SCC. A Cox proportional hazards model was used to estimate the hazard ratios (HRs) and 95% 95% CIs for esophageal SCC, with adjustment for potential confounders. An increase in consumption of total fruit and vegetables by 100 g per day (g/day) was associated with an 11% decrease in the incidence of esophageal SCC (95% CI: 1-21%). In particular a higher intake of cruciferous vegetables was associated with a significant decrease in risk (HR per 100 g/day: 0.44; 95% CI: 0.23–0.82)
- Hajizadeh et al. 2011 conducted a case control study titled fruits and vegetables consumption and esophageal squamous cell carcinoma. Study included 47 patients with esophageal SCC and 96 controls. Cases had higher tobacco consumption and symptomatic gastroesophageal reflux, whereas controls had higher mean body mass index (25.3 vs. 20.4) and years of education. A protective independent effect was observed for the highest tertile of total fruit consumption (odds ratio [OR]: 0.13, CI: 0.04–0.45, P = 0.001). Within the group of fruits, a significant inverse association was observed for bananas and kiwis (P for trends: 0.03 and 0.02, respectively). The risk of SCC decreased monotonically with increasing intake frequency of oranges (P value for trend = 0.01)
- Tabatabaei et al., 2011 conducted a case control study to find the association of Meat consumption and cooking practices and the risk of colorectal cancer. The amount of red baked meat consumed had a statistically significant inverse trend of association with CRC (Q4 OR = 0.73 95% CI: 0.53–1.01). The protective trends for red pan-fried meat were also borderline statistically significant. They examined the risk of CRC for people who ate their meat well done or very well done in comparison with those who ate their meat medium or rare)
- Magalhães et al., 2011 conducted a study titled dietary patterns and colorectal cancer: A case–control study from Portugal. This study was to quantify the association between dietary patterns and colon and rectum cancers. Study included 151 rectum and 102 colon cancer cases and 879 20 community controls. The OR estimates for rectum cancer and colon cancer were 3.12 and 1.41, respectively. Results confirm the higher risk of colorectal cancer among subjects with “western” diets and “low consumption of milk and foods containing foods containing dietary fiber. The pattern with high consumption of red and processed meat, refined cereals, sugar and sweets, potatoes, wine and alcoholic beverages, and low intake of wholegrain cereals and vegetable soup was associated with an increased risk of colon cancer”
- Banqué et al., 2012 conducted a Hospital-Based Case-Control Study in Spain to find the relation between food groups and nutrient intake and the risk of colorectal cancer included 245 patients with incident histologically confirmed CRC and 490 controls. ORs and multiple logistic regression model were used to measure the association between CRC and dietary variables. Vitamin B6 (OR: 0.26), vitamin D (OR: 0.45), vitamin E (OR: 0.42), polyunsaturated fatty acids (OR: 0.57), and fiber (OR: 0.40) were inversely associated with CRC, whereas carbohydrates (OR: 1.82) were significantly associated with CRC risk for the upper tertile
- Neil et al., 2012 conducted a Prospective Investigation for Dietary Fibre Intake and Risks of Cancers of the Colon and Rectum. After multivariable adjustments, total dietary fiber was inversely associated with colorectal cancer (HR per 10 g/day increase in fiber 0.87, 95% CI: 0.79–0.96). Fiber from cereals and fiber from fruit and vegetables were similarly associated with colon cancer; but for rectal cancer, the inverse association was only evident for fiber from cereals
- Teresa T. Fung et al. 2013 conducted a review study for Dietary Patterns and the Risk of Colorectal Cancer. This review examines the most common techniques for extrapolating dietary patterns and reviews dietary pattern/colorectal cancer studies published between September 2011 and August 2012. Results from investigations using a priori dietary patterns (i.e. diet quality scores) and a posteriori methods, which identify existing eating patterns (i.e. principal component analysis), continue to support the benefits of a plant-based diet with some dairy as a means to lower the risk of colorectal cancer, whereas a diet high in meats, refined grains, and added sugar appears to increase risk
- Aykan 2015 in his study titled Red meat and colorectal cancer It is a systematic literature search for publications on red and processed meat and colorectal cancer. Accumulated evidence of prospective epidemiological studies and their meta-analyses shows that red meat and processed meat convincingly increases CRC risk by 20%–30%. Regarding specific red meat subtypes, the association with increased risk was found for beef consumption in two trials (one of them is weakly associated), for pork consumption in three trials and for lamb intake in one trial. An interesting observation is the existence of this risk only for pork intake and rectum cancer and lamb intake and colon cancer, respectively in one trial
- Han et al., 2015 conducted a meta-analysis to summarize the evidence regarding the association between dietary fat intake and gastric cancer risk. Twenty-two articles were included in the meta-analysis. The summary RR for gastric cancer was 1.18 for individuals with highest intake versus lowest intake of total fat and 1.08 with a daily increase in total fat intake. Positive association between saturated fat intake and inverse association between polyunsaturated fat intake and vegetable fat intake, and no association between monounsaturated fat intake and animal fat intake and gastric cancers were observed
- Nunes et al. 2016 conducted a case control study in Brazil to evaluate the influence of dietary patterns on the risk of sporadic colorectal adenocarcinoma (SCA) in an ethnically heterogeneous population. The study population comprised 169 patients with histologically confirmed SCA and 110 control groups Patients reported higher average intakes of beef, chicken, and pork. These individuals had a 1.025-, 1.069-, and 1.121-fold increased risk of SCA. Similar consumption of fish, vegetables, fruits and whole grains was reported by patients and controls. Meat consumption is greater in patients with SCA in the Brazilian population
- Zhao et al., 2017 conducted a systematic review and meta-analysis for Red and processed meat consumption and colorectal cancer risk. Thirty-five studies of colorectal cancers (20 casecontrol studies and 15 cohort studies) were included. Positive associations were observed for colorectal cancer in casecontrol studies (red meat, P < 0.01; processed meat, P < 0.01) and cohort studies (red meat, P < 0.01; processed meat, P < 0.01) and the pooled RRs were 1.41 (1.17–1.71) for casecontrol studies and 1.12 (1.03–1.21) for cohort studies. In this systematic review and meta-analysis, we found consumption of red and processed meat was associated with the risk of overall colorectal cancer but not rectal cancer. Additionally, there were no associations between the consumption of red meat and distal colon cancer risk and between the consumption of processed meat and proximal colon cancer risk
- Shaw et al., 2017 conducted a cross sectional study titled Intake of dietary fiber and lifetime nonsteroidal anti-inflammatory drug (NSAID) use and the incidence of colorectal polyps in a population screened for colorectal cancer. Total dietary fiber intake was associated with a decreased presence of high-risk adenomatous polyp (HRAP). Ever use of NSAIDs was also inversely associated with HRAPs observed with monthly and daily use. Dietary fiber intake and NSAID use were associated with a decreased risk of having a HRAP at screening
- Zhao et al., 2018 performed a meta-analysis of studies to evaluate the incidence between citrus fruit consumption and subtypes of esophageal cancer. The result indicated the inverse associations between intakes of citrus fruit and EC (RR = 0.65, P = .001) and ESCC (RR = 0.59 P = 0.002). No significant relationship between citrus fruit and EAC (RR = 0.86 P = 0.598). This meta-analysis indicates that intakes of citrus fruit significantly reduce the risk of ESCC and is no obvious relationship with EAC.
To study the relationship of dietary pattern with selected GI cancers (esophageal, stomach, and colorectal cancers) using FFQ in Regional Cancer Centre, GMC, Jammu.
A case control study shall be conducted in the Department of Radiotherapy (Regional Cancer Center) at GMC, Jammu for a period of 1 year with effective from November 1, 2018, October 31, 2019, after seeking permission from Institutional Ethical Committee. This hospital is a tertiary care hospital and provides multispecialty and superspecialty services to the people of Jammu region and adjoining areas. The hospital has advanced diagnostic facilities aligned with Post Graduate Departments of Biochemistry, Pathology and Radiology.
| Study Setting|| |
The Radiotherapy Department of Government Medical College, Jammu started functioning in the year 1991 and was recognized as Regional Cancer Centre in 2011. Facilities available at Regional Cancer Center, GMC, Jammu are Telecobalt Machines, Microselection HDR Brachytherapy and conventional simulator. There are 30 beds available for in patients and 32 beds for outpatients (for day care chemotherapy and radiotherapy). 60–70 patients attend OPD daily, around 35–40 patients receive chemotherapy per day and 70–80 patients receive radiotherapy per day. Further, Hospital Based Cancer Registry (ICMR) is functional with its 2 components HBCR and Pattern of Care and Survival Studies since 2014 and is jointly run by Department of Radiotherapy and Postgraduate Department of Community medicine under ICMR-NCDIR. Around 2000 cancer patients on an average are registered under HBCR, GMC, Jammu each year.
| Study Design|| |
| Selection of Cases|| |
The following shall be considered eligible as a case:
- Newly diagnosed patients of esophageal, stomach or colorectal cancer
- Age >18 year
- Histopathologically confirmed
- Residents of Jammu and Kashmir for at least 10 years
- Those who give consent for participation
- Those who are willing for follow up.
| Exclusion Criteria|| |
- Age <18 years
- Subjects who are seriously ill, bed ridden, not able to communicate or with cognitive impairment
- No histopathological confirmation
- Those who have previously received any form of cancer directed treatment
- Those who are not willing to give consent
- Those who are not willing for follow-up.
The following participants shall be considered eligible as a control:
- Selection of Controls: Two controls shall be chosen for each case
- The controls shall be age and sex matched. The age matching shall be within ± 5 years
- One group of control shall be chosen from healthy population (sibling, friend, neighbor or healthy attendant of some other patient)
- Second group of control shall be chosen from newly diagnosed cases of cervical cancer in case of female cancer cases and newly diagnosed cases of head and neck cancer in case of male cancer cases
- Those who are willing to give consent
- Those who are willing for follow-up.
After taking consent from subjects (cases as well as controls) and briefing them about the purpose of the study in a language they can understand, the basic information about them shall be collected by filling the core form of HBCR. The core form has information regarding:
- Identifying information
- Basic Demographic parameters
- Diagnostics details
- Details of clinical stage and treatment.
After completion of core form, each case or control shall be subjected to in person interview using FFQ [Annexure 2]. The modified FFQ used in the present study shall be based on the work done by Telles et al. and Sudha et al. and modifications brought on by piloting on local populace. The FFQ consists of 123 food items and takes 20–30 min to complete. The Dietary information collected in FFQ shall relate to 1 year prior to the date of diagnosis. Similar time limit shall be used for controls also
FFQ has been broadly divided into two parts: Dietary pattern and lifestyle. Apart from dietary pattern, frequency and portion size shall also be assessed using standardized utensils.
| Plan of Analysis|| |
All the data thus obtained from both cases and controls shall be entered into Microsoft Excel and analyzed using SPSS version 21 (IBM Corp. Armonk, NY, USA) and OpenEpi toolkit Version 3.01. Dietary pattern, represented as proportions of cases and control consuming different food groups of interest shall be tabulated and compared. Relationship among dietary patterns and different cancers shall be assessed using Chi-square test for proportions and calculation of odds ratio with corresponding 95% CIs. A P < 0.05 shall be considered as statistically significant and all P values used shall be two tailed.
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[Table 1], [Table 2]