Fermented Foods for Rectal Cancer

Overseen By Stephanie Hogue

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Inflammatory bowel conditions, Infectious disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether eating fermented foods can improve treatment outcomes for people with locally advanced rectal cancer or non-small cell lung cancer (NSCLC). Participants will be divided into groups: one will follow a diet including fermented foods (the FEED-FF intervention), while the other will continue with standard healthy eating. The goal is to determine if fermented foods can help patients respond better to treatments like chemoradiation or immunotherapy. This trial suits those diagnosed with stage II-III rectal cancer or stage II-IV NSCLC who are about to start treatment at Moffitt Cancer Center. As an unphased trial, this study offers a unique opportunity to explore innovative dietary interventions that could enhance treatment effectiveness.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop using probiotics if you are currently taking them.

What prior data suggests that the FEED-FF dietary intervention is safe for cancer patients?

Research shows that fermented foods are generally safe, and most people can consume them without issues. In past studies, individuals who included fermented foods like yogurt, kimchi, and sauerkraut in their diets reported only minor side effects.

Although specific safety data for the exact FEED-FF treatment is not available, fermented foods are consumed worldwide and are known to benefit gut health. Any negative reactions are usually mild, such as bloating or gas, which can occur when trying new foods.

The trial for FEED-FF is in a phase that evaluates its practicality and acceptability, indicating confidence in its safety for participants. For any concerns, consulting a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for rectal cancer, such as surgery, chemotherapy, and radiation, the study treatment, FEED-FF, focuses on the potential benefits of consuming fermented foods. Researchers are excited about this approach because fermented foods are rich in probiotics, which might improve gut health and possibly enhance the body's ability to fight cancer. This dietary intervention could offer a less invasive, more holistic complement to existing therapies, potentially improving quality of life and reducing treatment side effects. By examining dietary impacts, researchers aim to uncover new ways to support cancer patients beyond standard medical treatments.

What evidence suggests that the FEED-FF dietary intervention could be effective for rectal cancer and NSCLC patients?

This trial will compare a high-fermented food intervention (FEED-FF) with standard care for rectal cancer patients. Research has shown that eating fermented foods can strengthen the immune system, which is crucial for cancer patients as a strong immune system can help fight cancer. Early studies suggest that these foods might also improve gut health, which is linked to better overall health. Some patients who consumed fermented foods during cancer treatment reported feeling better and experiencing fewer side effects. However, more research is needed to confirm these benefits specifically for rectal and lung cancer. ^{1 2 3 4 5}

Who Is on the Research Team?

Doratha (Armen) Byrd, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with locally advanced rectal cancer who are about to receive chemoradiotherapy. Participants should be willing to follow a special diet that includes fermented foods and meet other study requirements.

Inclusion Criteria

Able to speak and read English

Able to consume foods orally

Able to provide informed consent

Exclusion Criteria

Already consuming ≥2 servings of fermented foods/day

Previously diagnosed with a mast cell disorder or histamine allergy

I have not taken antibiotics in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants receive a dietary intervention with fermented foods, consuming 3-6 servings per day from 1 week prior to treatment start through 12 weeks after treatment start.

13 weeks

3 visits (in-person) for biospecimen collection and surveys at baseline, week 6.5, and week 12.5

Treatment

Rectal cancer patients receive chemoradiation and NSCLC patients receive immunotherapy.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clinical response and quality of life assessments.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FEED-FF

Trial Overview The FEED Trial is testing the effects of a high-fermented food diet (FEED-FF) on patients with rectal cancer during their standard chemoradiotherapy treatment, aiming to see if it can improve outcomes.

How Is the Trial Designed?

Group I: FEED-FF Experimental Treatment 1 Intervention

Participants will be asked to pick up the fermented foods at the Research Kitchen at Moffitt. Participants will be asked to eat 3-6 servings of FFs per day, from 1 week prior to treatment start through 12 weeks after treatment start/until the restaging scope is completed. At baseline, the end of week 6.5 and again at week 12.5, participants will be asked to provide biospecimens including a stool sample collected at home and a blood specimen collected in clinic. Participants will be asked to complete a food frequency questionnaire, a quality-of-life survey, two symptom related surveys, and a stool collection questionnaire at these same timepoints. After the dietary intervention, participants will be asked to complete an exit survey to provide feedback on the study and intervention.

Group II: Standard of Care (SUC) Active Control 1 Intervention

Participants will receive general healthy eating handouts similar to current usual care documents provided in clinic. These handouts will detail typical healthy foods and the suggested level of intake, or servings per day. At baseline, the end of week 6.5 and again at week 12.5, participants will be asked to provide biospecimens including a stool sample collected at home and a blood specimen collected in clinic. Participants will be asked to complete a food frequency questionnaire, a quality-of-life survey, two symptom related surveys, and a stool collection questionnaire at these same timepoints.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Published Research Related to This Trial

Fermentation of the nondigested fraction from common beans by human gut flora produces short-chain fatty acids, particularly butyrate, which may help reduce the risk of colorectal tumors.

The fermentation products from these beans inhibited the growth of human colon cancer cells (HT-29) and influenced protein expression related to apoptosis and cell cycle regulation, suggesting a potential chemoprotective effect against colon cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human gut flora-fermented nondigestible fraction from cooked bean ( Phaseolus vulgaris L.) modifies protein expression associated with apoptosis, cell cycle arrest, and proliferation in human adenocarcinoma colon cancer cells. Campos-Vega, R., García-Gasca, T., Guevara-Gonzalez, R., et al.[2012]

Fermentation of wheat aleurone with probiotics LGG and Bb12 increased butyrate levels, which is beneficial for colon health, but only slightly enhanced fermentation efficiency.

The fermented aleurone significantly inhibited cell growth and promoted apoptosis in human colon adenoma and adenocarcinoma cells, suggesting its potential as a protective agent against colon cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermented wheat aleurone enriched with probiotic strains LGG and Bb12 modulates markers of tumor progression in human colon cells. Borowicki, A., Michelmann, A., Stein, K., et al.[2017]

Fermented wheat aleurone significantly increases levels of short-chain fatty acids (SCFA), which may help protect against colon cancer by promoting apoptosis and inhibiting the growth of cancer cells, specifically HT29 cells, in vitro.

The study found that fermented wheat aleurone reduced tumor-promoting bile acids and effectively arrested the cell cycle in the G0/G1 phase, indicating its potential as a functional food for cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermented wheat aleurone inhibits growth and induces apoptosis in human HT29 colon adenocarcinoma cells. Borowicki, A., Stein, K., Scharlau, D., et al.[2017]

Dietary fiber, particularly from vegetables, may have a protective effect against colorectal cancer, as suggested by numerous case-control studies, although the exact mechanisms remain to be fully understood.

Starch appears to enhance the fermentation process in the gut, leading to the production of beneficial short-chain fatty acids like butyrate, which may help protect against colorectal cancer by providing energy to colonic cells and inhibiting cell proliferation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms and experimental and epidemiological evidence relating dietary fibre (non-starch polysaccharides) and starch to protection against large bowel cancer. Bingham, SA.[2019]

Fermentation supernatant fractions of inulin significantly increased short-chain fatty acids (SCFA) and decreased harmful bile acids, showing potential protective effects against colorectal cancer.

In human colon cell lines, particularly in early-stage cancer cells (LT97), the fermentation supernatant induced apoptosis and inhibited cell growth, suggesting that prebiotic fibers like inulin could play a role in cancer chemoprevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermentation products of inulin-type fructans reduce proliferation and induce apoptosis in human colon tumour cells of different stages of carcinogenesis. Munjal, U., Glei, M., Pool-Zobel, BL., et al.[2022]

The fermented nondigestible fraction (FNDF) from the Negro 8025 bean cultivar significantly inhibited the survival of human colon adenocarcinoma HT-29 cells, with a lethal concentration (LC50) of 13.63% FNDF, indicating its potential as a chemoprotective agent against colon cancer.

The FNDF produced higher levels of butyrate and had a lower pH compared to control, suggesting that the fermentation process enhances the production of beneficial short-chain fatty acids that may contribute to the observed anti-cancer effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermented nondigestible fraction from common bean (Phaseolus vulgaris L.) cultivar Negro 8025 modulates HT-29 cell behavior. Cruz-Bravo, RK., Guevara-Gonzalez, R., Ramos-Gomez, M., et al.[2017]

Patients with colorectal cancer consumed more energy from fats, proteins, and carbohydrates compared to matched control subjects, but their diets were significantly lower in cereal fiber, riboflavin, calcium, and phosphorus.

Higher intakes of cereal fiber, calcium, and total fiber were associated with a reduced risk of colorectal cancer, while high alcohol consumption was linked to an increased risk, supporting previous research on diet and cancer incidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cereal fiber, calcium, and colorectal cancer. Arbman, G., Axelson, O., Ericsson-Begodzki, AB., et al.[2019]

The study found that the gut bacterium Fusobacterium nucleatum, often linked to colorectal cancer (CRC), can have both harmful and beneficial effects depending on dietary fiber intake, influencing the growth of cancer cells.

When cultured with dietary fibers like polydextrose and fibersol-2, F. nucleatum produced more butyrate, which inhibited the growth of cancer cells (Caco-2) significantly, suggesting that dietary composition can alter the role of gut microbiota in CRC risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pathogenicity of Fusobacterium nucleatum Modulated by Dietary Fibers-A Possible Missing Link between the Dietary Composition and the Risk of Colorectal Cancer. Nawab, S., Bao, Q., Ji, LH., et al.[2023]

Dietary fiber plays a crucial role in reducing the risk of colonic cancer, primarily through the process of colonic fermentation, which produces beneficial short-chain fatty acids.

Resistant starch, which is not fully digested in the small intestine, serves as a significant source of fermentable substrate, potentially enhancing the protective effects against colon cancer by lowering colonic pH and reducing harmful secondary bile acids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of carbohydrate fermentation in colon cancer prevention. Van Munster, IP., Nagengast, FM.[2019]

Inulin-rich meat products, such as chorizo sausages and cooked ham, significantly reduced colon polyp formation by 49% in an animal model, indicating their potential as preventive foods against colorectal cancer.

The functional meat products not only increased beneficial short-chain fatty acids like propionate and butyrate but also altered gut microbiota composition, enhancing beneficial bacteria while reducing pro-inflammatory populations, suggesting a multifaceted approach to cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Processed Meat Products Re-designed Towards Inulin-rich Functional Foods Reduce Polyps in Two Colorectal Cancer Animal Models. Fernández, J., Ledesma, E., Monte, J., et al.[2023]

In a study involving 216 male Fischer 344 rats, certain dietary fibers like polydextrose and wheat bran significantly reduced colon tumor incidence compared to a control diet, suggesting their protective effects against tumorigenesis.

The study found that the fermentation characteristics of different carbohydrates play a crucial role in tumor outcomes, with specific fibers leading to fewer tumors and lower tumor burden in the colon, highlighting the importance of dietary fiber type in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermentable Carbohydrates Differentially Affect Colon Tumor Formation in Azoxymethane-Induced Male Fischer 344 Rats. Raju, J., Roberts, J., Chen, Q., et al.[2023]

Citations

1. cancer.gov cancer.gov/clinicaltrials/NCI-2024-03115

High-Fermented Food Intervention (FEED-FF) to Improve ... This clinical trial tests the effect of FEED-FF, a fermented foods (FF) dietary intervention, during chemoradiotherapy on outcomes in patients with stage II- ...

2. moffitt.org moffitt.org/clinical-trials-and-studies/clinical-trial-22709/

Clinical Trial 22709 This Study will determine if a fermented foods (FF) dietary intervention (called FEED-FF) will be feasible and acceptable among participants with rectal cancer ...

3. withpower.com withpower.com/trial/phase-rectal-neoplasms-1-2024-22cc0

Fermented Foods for Rectal Cancer The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06337552/high-fermented-food-intervention-among-locally-advanced-rectal-cancer-patients-the-feed-trial

High-Fermented Food Intervention Among Locally ... The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods ...

5. ctv.veeva.com ctv.veeva.com/study/high-fermented-food-intervention-among-locally-advanced-rectal-cancer-patients-the-feed-trial

High-Fermented Food Intervention Among Locally Advanced ... The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods ...