Dietary Interventions for Cancer

Overseen By Hassane M Zarour, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must be taking: Immune checkpoint inhibitors

Must not be taking: Antibiotics, Corticosteroids, Cytokines, others

Disqualifiers: Chronic alcohol, Major GI surgery, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different diets might boost the immune system to fight cancer. It focuses on high-fermented foods and fiber supplements to determine if they can positively change the gut microbiome—the collection of bacteria in the intestines—and improve immune responses in patients with melanoma and non-small cell lung cancer (NSCLC) receiving certain immune therapies. Patients with melanoma or NSCLC who are currently receiving or about to start specific cancer immunotherapies might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance cancer treatment options.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, such as systemic antibiotics, corticosteroids, cytokines, methotrexate, immunosuppressive agents, and probiotics or fiber supplements, at least 14 days before starting the diet. Additionally, systemic antibiotics and proton pump inhibitors must be discontinued more than 21 days prior to the study.

What prior data suggests that these dietary interventions are safe for patients with melanoma and NSCLC?

Research has shown that eating fermented foods can increase the variety of beneficial bacteria in the gut and boost the immune system. These foods are usually easy to digest and may benefit gut health. Studies have not identified any major safety issues with consuming fermented foods.

Regarding high-fiber supplements, research has found that increased fiber intake is linked to a lower risk of certain cancers, such as colon and breast cancer. This suggests that fiber is safe for most people and may help protect against these cancers.

Both consuming fermented foods and taking high-fiber supplements are generally safe and may offer additional health benefits, particularly for gut health and reducing cancer risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these dietary interventions for cancer because they take a unique approach by focusing on nutrition rather than pharmaceuticals. Unlike traditional cancer treatments like chemotherapy and radiation, which target cancer cells directly, this method aims to support the body’s natural defenses. The combination of high-fermented foods and high fiber supplementation is believed to enhance gut health, which could potentially boost the immune system and improve the body’s ability to fight cancer. This natural and potentially less invasive approach offers a promising complement to existing treatment options, with the added benefit of potentially fewer side effects.

What evidence suggests that these dietary interventions could be effective for melanoma and NSCLC?

This trial will evaluate the effects of a high-fermented food diet combined with high-fiber supplementation. Research has shown that consuming fermented foods can increase the diversity of gut bacteria and enhance immune function. A diverse gut microbiome is important for a strong immune system. Studies also suggest that fermented foods might lower the risk of certain cancers.

High-fiber supplements show promise as well. One study found that adding just 5 grams of fiber to the daily diet reduced the risk of melanoma progression by 30%. Increased fiber intake has been linked to lower risks of various cancers and improved survival rates. These findings suggest that both dietary changes might help the body combat cancer in individuals with melanoma and non-small cell lung cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Hassane M Zarour, MD

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

This trial is for melanoma and NSCLC cancer patients undergoing standard immune checkpoint inhibitor therapy. It's designed to see if certain diets can help their treatment work better.

Inclusion Criteria

Be willing and able to provide written informed consent

Patients must have any type of electronic device such as a smartphone, tablet, or computer etc that can access the internet

Body mass index (BMI) 18.5-40 kg/m2

Exclusion Criteria

Pregnant or nursing (lactating) women

Current consumption of fiber ≥20g or fermented food ≥3 portions a day

I have not taken antibiotics or proton pump inhibitors in the last 21 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

High-Fermented Food Diet

Participants consume a high-fermented food diet to study its impact on gut microbiome and systemic inflammation

4 weeks

Weekly stool samples, blood samples every 2-4 weeks

Break/Observation

Participants have a break period where they can eat any type of food without dietary restrictions

2 weeks

High-Fiber Supplementation

Participants receive high-fiber supplementation to study its impact on gut microbiome and systemic inflammation

4 weeks

Weekly stool samples, blood samples every 2-4 weeks

Break/Observation

Participants have a break period where they can eat any type of food without dietary restrictions

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after dietary interventions

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Interventions

Trial Overview The study tests the effects of high-fermented foods and high-fiber supplements on gut bacteria and how they might boost the body's response to cancer immunotherapy in these patients.

How Is the Trial Designed?

Group I: high-fermented food + high fiber supplementation Experimental Treatment 2 Interventions

Step 1: patients will consume high-fermented food Step 2: High fiber supplementation

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

This study is a double-blinded, randomized controlled trial involving 60 Alaska Native participants to assess whether dietary fiber supplementation can significantly reduce colorectal cancer risk, particularly in a population with the highest reported incidence of CRC.

Participants will be monitored for changes in inflammatory and proliferative biomarkers related to cancer risk after an 8-week period of fiber supplementation, with additional assessments of gut microbiota and metabolites, ensuring a comprehensive evaluation of the intervention's effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fibre to reduce colon cancer risk in Alaska Native people: the Alaska FIRST randomised clinical trial protocol. Koller, KR., Wilson, A., Normolle, DP., et al.[2021]

A high-fiber diet is associated with a reduced risk of several cancers, particularly colon cancer, with 25 out of 32 studies showing this protective effect since 1980.

While many studies indicate that fiber-rich foods may lower cancer risk, it's challenging to determine if fiber alone is responsible for this effect, suggesting that overall dietary patterns are more important than just fiber supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber and cancer prevention. Shankar, S., Lanza, E.[2017]

In a study involving 75 healthy participants, supplementation with resistant starch (RS) and polydextrose for 50 days did not change fecal calprotectin levels, indicating no immediate inflammatory response in the gut.

Both RS and polydextrose significantly reduced the expression of SFRP1, which may lead to increased Wnt pathway activity, suggesting a potential mechanism by which these dietary fibers could influence colorectal cancer risk, although further research is needed to explore the functional effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of supplementation with nondigestible carbohydrates on fecal calprotectin and on epigenetic regulation of SFRP1 expression in the large-bowel mucosa of healthy individuals. Malcomson, FC., Willis, ND., McCallum, I., et al.[2023]

In a study involving 96 rats, high-fiber diets containing resistant starch (RS) and short-chain fructo-oligosaccharides (FOS) were found to produce significant amounts of butyrate, which is linked to a healthier colon environment.

Rats fed these butyrate-producing diets showed a reduced number of aberrant crypt foci, a marker of potential colon cancer, suggesting that these specific fibers may help protect against colon carcinogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Only fibres promoting a stable butyrate producing colonic ecosystem decrease the rate of aberrant crypt foci in rats. Perrin, P., Pierre, F., Patry, Y., et al.[2019]

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]

Fermentation of dietary soluble fibers by gut bacteria produces beneficial short-chain fatty acids (SCFAs) that support health and can serve as food supplements.

However, a study highlighted that while these fibers improve metabolic dysfunction, they may also induce cholestasis and increase the risk of hepatocellular carcinoma (HCC), indicating a complex relationship between fiber intake and liver health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When Soluble Fibers Meet Hepatocellular Carcinoma: The Dark Side of Fermentation. Gallage, S., Kotsiliti, E., Heikenwalder, M.[2018]

High fiber consumption is generally associated with lower colon cancer rates in humans, particularly from cereal fiber sources, although case-control studies do not consistently confirm a protective effect from dietary fiber alone.

Laboratory studies indicate that poorly fermentable fibers like wheat bran may protect against colon cancer, while some fermentable fibers can actually enhance tumor development, suggesting that the type of fiber and its properties play a crucial role in cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between dietary fiber and cancer: metabolic, physiologic, and cellular mechanisms. Jacobs, LR.[2020]

About 50% of cancer cases and 35% of cancer deaths in the U.S. are linked to Western dietary habits, highlighting the importance of nutrition in cancer prevention.

Optimizing diet by reducing caloric intake and fat (to 20% or less of total calories) while increasing fiber (to 25-35 g per day) can significantly lower cancer risk and promote overall health, as suggested by the Fiber First Diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and cancer prevention: the fiber first diet. Williams, GM., Williams, CL., Weisburger, JH.[2017]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1756464620305053

An insight into the anticancer effects of fermented foods In this context, it is stated that certain nutrient components in fermented foods may decrease the risk of cancer (Rai & Jeyaram, 2015).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11606817/

Effects of simultaneous intake of dietary fermented foods and ... Therefore, this study found that fermented foods did not significantly affect CRC risk indicators associated with dietary processed meat intake ...

3. med.stanford.edu med.stanford.edu/news/all-news/2021/07/fermented-food-diet-increases-microbiome-diversity-lowers-inflammation.html

Fermented-food diet increases microbiome diversity ... Stanford researchers discover that a 10-week diet high in fermented foods boosts microbiome diversity and improves immune responses.

4. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1409414/full

Eating away cancer: the potential of diet and ... This review will discuss the role of the GMB and diet on anti-cancer immunity. We demonstrate that diet affects anti-cancer immunity through both GMB- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9174999/

Fermented Dairy Food Intake and Risk of Colorectal Cancer Furthermore, we also found that the higher intake of yogurt may lower the risk of rectal cancer (OR = 0.75, 95% CI = 0.65–0.88) in cohort ...

6. nature.com nature.com/articles/s41598-024-83722-8

Effect of dietary probiotics intake on cancer mortality However, high dietary probiotic intake was linked to a lower cancer risk exclusively in males (HR = 0.687; 95% CI: 0.527–0.895) (eTable 3).