High Fiber Diet for Lung Cancer
Recruiting in Palo Alto (17 mi)
Overseen byBertrand Routy, MD,PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Must be taking: Immune checkpoint inhibitors
Disqualifiers: Severe dietary allergies, Psychiatric disorders, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This is a single-center randomized trial in patients with non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibition. Patients will receive standard-of-care immune checkpoint inhibitor (ICI) therapy alone or in combination with a dietary intervention.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment 'High Fiber Diet for Lung Cancer'?
Research suggests that nutritional counseling and a diet rich in fiber and other nutrients can improve the quality of life and treatment response in lung cancer patients. Proper nutrition helps maintain body weight and energy levels, which are crucial during cancer treatment.
12345Is a high fiber diet safe for humans?
A high fiber diet is generally safe for humans, with mild side effects like abdominal discomfort and gas. Some people may need to supplement with minerals like calcium and iron when increasing fiber intake.
678910How does a high fiber diet differ from other treatments for lung cancer?
A high fiber diet is unique because it focuses on dietary changes rather than medication or surgery, potentially offering a non-invasive approach to support lung cancer treatment. While fiber is known for its benefits in reducing colon cancer risk, its role in lung cancer is less established, making this approach novel in exploring dietary impacts on lung cancer.
67111213Eligibility Criteria
This trial is for adults over 18 with confirmed non-small cell lung cancer (NSCLC) who are being treated with standard immune checkpoint inhibitors and can eat solid foods. It's not suitable for those with severe dietary allergies or psychiatric/substance abuse issues that could affect participation.Inclusion Criteria
I am 18 years old or older.
Signed, informed consent
I have been diagnosed with non-small cell lung cancer and am treated with standard immune checkpoint inhibitors.
+1 more
Exclusion Criteria
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
You have severe allergies to certain foods like shellfish, nuts, or seafood.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive standard-of-care immune checkpoint inhibitor (ICI) therapy alone or in combination with a dietary intervention
12 weeks
3 visits (in-person) at baseline, 6 weeks, and 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing if increasing total fiber intake affects the effectiveness of standard immune therapy in NSCLC patients. Participants will either continue their normal diet or follow a high-fiber diet alongside their regular cancer treatment.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Patients in the intervention arm will complete a dietary survey and be counselled on increasing their total fiber intake. Intervention group will have dietary survey and 24-hour recall survey at baseline, at 6 weeks, and at 12 weeks relative to ICI initiation.
Group II: Control GroupActive Control1 Intervention
Patients in the control arm will complete the dietary survey without dietary intervention or counselling from a dietician. Control group will have dietary survey and 24-hour recall survey at baseline, at 6 weeks, and at 12 weeks relative to ICI initiation.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centre hospitalier de l'Université de Montréal (CHUM)Montréal, Canada
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Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
References
The Role of Nutritional Support in Malnourished Patients With Lung Cancer. [2022]This review aimed to aggregate and describe the available data about clinical nutrition in lung cancer and the role of the dietitian in multidisciplinary patient care. Scientific literature was searched in order to summarize key aspects related to clinical nutrition in lung cancer. This information can be used to arrange a proper nutritional therapy that can enhance patient treatment responses, prevent side-effects, shorten recovery time, improve prognosis and increase quality of life. An anti-inflammatory diet rich in antioxidants, immunomodulatory compounds, dietary fibre and an appropriate intake of protein can reduce the risk of initiation and progression of lung cancer, support the regeneration of tissues (also after surgery) and improve the nutritional status during the disease and after remission. A correct intake of nutrients is significant prior to disease occurrence and at every stage of treatment and recovery.
Effect of dietary counseling on food intake, body weight, response rate, survival, and quality of life in cancer patients undergoing chemotherapy: a prospective, randomized study. [2017]This study examined the effect of frequent nutritional counseling on oral intake, body weight, response rate, survival, and quality of life in patients with cancer of the lung (small-cell), ovary, or breast undergoing cyclic chemotherapy.
The effect of nutrition intervention in lung cancer patients undergoing chemotherapy and/or radiotherapy: a systematic review. [2018]The prevalence of malnutrition in lung cancer patients across a variety of treatment modalities and disease stages ranges from 45% to 69%. Malnutrition is associated with poorer clinical outcomes in cancer patients. This systematic review examined whether dietary counseling or oral supplements during chemotherapy and/or radiotherapy in patients with lung cancer affect patient or clinical outcomes. Relevant nutrition intervention studies from 1980 to March 2012 were identified. Articles meeting predetermined inclusion/exclusion criteria were critically appraised and included in the review. The outcomes of interest included dietary intake, weight, nutritional status, quality of life, functional status, treatment response, and survival. Five eligible studies were identified including 3 randomized controlled trials, 1 historical cohort, and 1 case series. These studies suggest dietary counseling improves energy and protein intake during chemotherapy in patients with lung cancer but has no benefit to other outcomes during chemotherapy. There is insufficient evidence regarding the effect on patient or clinical outcomes during radiotherapy. Randomized trials examining dietary counseling in patients with lung cancer during radiotherapy are required.
Nutrition screening and counseling in adults with lung cancer: a systematic review of the evidence. [2022]Maintenance of adequate nutrition is an integral component of the cancer treatment process. Numerous factors should be considered when evaluating the nutritional status of patients with cancer. A systematic review of the literature revealed the importance of nutrition interventions in patients with cancer who were undergoing chemotherapy. Counseling in nutrition has been shown to improve quality of life, strengthen response to therapy, and increase survival. Lung cancer presents a significant risk as the leading cause of cancer morbidity and mortality in the United States. In addition, nutritional deficiencies are experienced by most adults with lung cancer during the course of their disease and treatment. The deficiencies compound the cost of treatment and also increase morbidity and mortality in this patient population. Further study of nutritional interventions is needed to promote better outcomes and quality of life in patients with lung cancer.
Accelerated rehabilitation combined with enteral nutrition in the management of lung cancer surgery patients. [2021]To investigate the effect of accelerated rehabilitation combined with enteral nutrition on surgically treated lung cancer patients.
Role of dietary fiber in colon cancer: an overview. [2019]Studies have demonstrated a reduced risk of colon cancer when populations with diets high in total fat switched to a diet high in total fiber and certain whole-grain foods. Case-control studies have shown convincingly the relationship between dietary fiber and colon cancer. Studies in animal models have demonstrated that the inhibitory effects of dietary fiber on the development of colonic neoplasms depend on the nature and source of the fiber; that wheat bran appears to inhibit colon tumor development more consistently than do other dietary sources of fiber, such as oat and corn bran; and that dietary administration of phytic acid, high levels of which are present in wheat bran, inhibits colon carcinogenesis. Human dietary intervention studies have also indicated that the modifying effect of dietary fiber on bacterial enzymes involved in the production of putative colon tumor promoters depends on the type of fiber consumed. Dietary wheat bran, but not oat or corn bran, significantly decreased the levels of several tumor promoters in the colon, independent of stool bulk.
Dietary fiber and colon cancer: animal model studies. [2019]Support for a protective role for certain dietary fibers in the etiology of colon cancer has come from nutritional epidemiologic studies. Recommendations to increase consumption of fiber-containing food and decrease the intake of dietary fat should form the basis of a diet that is unlikely to do harm, and may have the potential for reducing the development of colon cancer, in humans. Studies examining the role of dietary fiber as an inhibitor of colon cancer in animal models appear to have provided some conflicting results, due mostly to differences in the nature and amount of carcinogen used to induce colon tumors, variation in the composition of the experimental diets, and relative difference in food intake by animals, to cite a few of the methodological problems. However, overall, the feeding of wheat bran appears to inhibit color tumor development to a greater degree than do other dietary sources of fiber.
The fiber metabolite butyrate reduces gp130 by targeting TRAF5 in colorectal cancer cells. [2022]Dietary fiber is effective for colorectal cancer (CRC) treatment. Interleukin-6 (IL-6) and its adaptors are potential targets for CRC therapy. Butyrate, a metabolite of dietary fiber, is a new, highly safe type of targeted drug.
Dietary fiber and cancer: a supplement for intervention studies. [2017]Dietary fiber is one of several variables being considered in the study of the relationship between diet and cancer. Intervention trials in which dietary fiber is increased are the most direct way of assessing the possible role of fiber in this disease. Two dietary snack products have been developed for use in a fiber intervention study: the high-fiber snack (HFS), which supplies 23 g of dietary fiber per day (mostly from wheat bran) and the low-fiber product (LFS), which provides 3.5 g. Over a 12-week period, 28 volunteers consumed the HFS for 6 weeks and the LFS for 6 weeks. Compliance, as assessed by reports, through recovery of a riboflavin marker in the urine and fecal fiber analysis, was good. The only adverse effects reported were mild abdominal discomfort and gas. Serum ferritin and calcium decreased in some subjects, indicating a need to supplement the products with these essential minerals. Consumption of the snacks did not affect total energy intake or the intake of the nutrients monitored.
Dietary fiber, vegetables, and colon cancer: critical review and meta-analyses of the epidemiologic evidence. [2022]Whether colon cancer risk can be modified by a diet rich in vegetables, grains, and fruit, and, if so, whether the protective factor is dietary fiber or other biologically active components correlated with a high-fiber diet are questions of active research interest. Because studies on diet are susceptible to bias from a number of sources, in this review we evaluated the adequacy of study methodology as well as study results to clarify how much protection, if any, is conferred by a high-fiber diet. The review consisted of an aggregate assessment of the strength of evidence from 37 observational epidemiologic studies as well as meta-analyses of data from 16 of the 23 case-control studies. Both types of analyses revealed that the majority of studies gave support for a protective effect associated with fiber-rich diets; an estimated combined odds ratio (OR) of 0.57 (95% confidence interval = 0.50, 0.64) was obtained when the highest and lowest quantiles of intake were compared. Risk estimates based on vegetable consumption (OR = 0.48) were only slightly more convincing than those based on an estimate of fiber intake (OR = 0.58), but the data do not permit discrimination between effects due to fiber and nonfiber effects due to vegetables.
Relationship between dietary fiber and cancer: metabolic, physiologic, and cellular mechanisms. [2020]The relationships between fiber consumption and human cancer rates have been examined, together with an analysis of the effects of individual dietary fibers on the experimental induction of large bowel cancer. The human epidemiology indicates an inverse correlation between high fiber consumption and lower colon cancer rates. Cereal fiber sources show the most consistent negative correlation. However, human case-control studies in general fail to confirm any protective effect due to dietary fiber. Case-control studies indicate that if any source of dietary fiber is possibly antineoplastic then it is probably vegetables. These results may mean that purified fibers alone do not inhibit tumor development, whereas it is likely that some other factors present in vegetables are antineoplastic. Experiments in laboratory animals, using chemical induction of large bowel cancer, have in general shown a protective effect with supplements of poorly fermentable fibers such as wheat bran or cellulose. In contrast, a number of fermentable fiber supplements including pectin, corn bran, oat bran, undegraded carageenan, agar, psyllium, guar gum, and alfalfa have been shown to enhance tumor development. Possible mechanisms by which fibers may inhibit colon tumorigenesis include dilution and adsorption of any carcinogens and/or promoters contained within the intestinal lumen, the modulation of colonic microbial metabolic activity, and biological modification of intestinal epithelial cells. Dietary fibers not only bind carcinogens, bile acids, and other potential toxins but also essential nutrients, such as minerals, which can inhibit the carcinogenic process. Fermentation of fibers within the large bowel results in the production of short chain fatty acids, which in vivo stimulate cell proliferation, while butyrate appears to be antineoplastic in vitro. Evidence suggests that if dietary fibers stimulate cell proliferation during the stage of initiation, then this may lead to tumor enhancement. Fermentation also lowers luminal pH, which in turn modifies colonic microbial metabolic acidity, and is associated with increased epithelial cell proliferation and colon carcinogenesis. Because dietary fibers differ in their physiochemical properties it has been difficult to identify a single mechanism by which fibers modify colon carcinogenesis. Clearly, more metabolic and physiological studies are needed to fully define the mechanisms by which certain fibers inhibit while others enhance experimental colon carcinogenesis.
Associations between dietary fiber and colorectal polyp risk differ by polyp type and smoking status. [2023]The association of dietary fiber intake with colorectal cancer risk is established. However, the association may differ between cigarette smokers and nonsmokers. We evaluated this hypothesis in a large colonoscopy-based case-control study. Dietary fiber intakes were estimated by self-administered food frequency questionnaire. Unconditional logistic regression analysis was used to estimate ORs and 95% CIs with adjustment for potential confounders. Analysis also was stratified by cigarette smoking and sex. High dietary fiber intake was associated with reduced risk of colorectal polyps (P-trend = 0.003). This association was found to be stronger among cigarette smokers (P-trend = 0.006) than nonsmokers (P-trend = 0.21), although the test for multiplicative interaction was not statistically significant (P = 0.11). This pattern of association was more evident for high-risk adenomatous polyps (ADs), defined as advanced or multiple ADs (P-interaction smoking and dietary fiber intake = 0.09). Among cigarette smokers who smoked ≥23 y, a 38% reduced risk of high-risk ADs was found to be associated with high intake of dietary fiber compared with those in the lowest quartile fiber intake group (P-trend = 0.004). No inverse association with dietary fiber intake was observed for low-risk ADs, defined as single nonadvanced ADs. Cigarette smoking may modify the association of dietary fiber intake with the risk of colorectal polyps, especially high-risk ADs, a well-established precursor of colorectal cancer.
Effect of wheat bran fiber on the development of mammary tumors in female intact and ovariectomized rats treated with 7,12-dimethylbenz(a)anthracene and in mice with spontaneously developing mammary tumors. [2019]We examined the effect of consumption of graded increases of dietary fiber (soft white wheat bran) on the development of mammary gland carcinomas in intact female Sprague-Dawley rats during the promotion stage of carcinogenesis, induced with 7,12-dimethylbenz(a)anthracene (DMBA). The percent of rats with mammary carcinomas, the total number of mammary carcinomas and the mean number of mammary carcinomas per rat were reduced significantly at all fiber levels examined compared to rats fed a control diet. Inclusion of 9.6% fiber in the diets of ovariectomized rats that had been treated with a single i.v. dose of 2.5 mg DMBA/100 g body weight 2 weeks prior to removal of the ovaries resulted in a significant decrease of carcinomatous and benign mammary tumors compared to ovariectomized rats fed a control diet. Development of spontaneous mammary carcinomas in virgin C3H/HeOuJ female mice and growth of a transplantable mammary gland tumor in such mice were reduced by inclusion of 9.6% fiber in the diet, a reduction that was significant or just barely missed significance, depending on the source of the fiber. Our observations provide evidence that inclusion of soft white wheat bran in the diet is effective in the suppression of mammary gland tumorigenesis in an array of experimental animal models.