Prebiotic Diet for Melanoma

Overseen By Jennifer McQuade, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: Immune checkpoint inhibitors

Must not be taking: Steroids, Antibiotics, Prebiotic supplements

Disqualifiers: Uveal melanoma, Inflammatory bowel disease, Insulin-dependent diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effects of a diet rich in prebiotic foods on people with melanoma (a type of skin cancer) who are about to start immune therapy. Prebiotics are foods that promote the growth of beneficial bacteria in the gut. Participants will receive snacks and guidance to increase their intake of these foods. This trial suits individuals diagnosed with advanced melanoma who are ready to begin immune therapy and are willing to adjust their diet to include more prebiotic foods. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance melanoma treatment through dietary changes.

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 cannot participate if you are taking steroids over a certain dose, certain supplements, or have used antibiotics recently. It's best to discuss your specific medications with the trial team.

What prior data suggests that this prebiotic diet is safe for participants with melanoma?

Research has shown that prebiotic diets are generally safe. In studies where participants consumed diets rich in prebiotic foods (PreFED), they tolerated the diet well, with no major harmful side effects reported. Prebiotics are special fibers in foods that promote the growth of beneficial gut bacteria, which can enhance digestion and overall health.

While specific data on PreFED for melanoma is limited, prebiotics are present in everyday foods like bananas and onions, suggesting they are safe for most people. Some individuals might experience mild digestive changes, such as gas or bloating, as their bodies adjust.

Overall, research indicates that prebiotics in diets are well-tolerated, making them a promising area for further study in supporting people with melanoma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for melanoma, which often involve surgery, chemotherapy, or immunotherapy, the Prebiotic food-enriched diet (PreFED) focuses on enhancing the gut microbiome. Researchers are excited about this treatment because it aims to boost the body's natural immune responses by increasing the intake of prebiotic foods. This innovative approach could potentially improve the effectiveness of existing therapies and offer a non-invasive option with fewer side effects. By harnessing the power of nutrition, PreFED has the potential to support overall health while specifically targeting melanoma's progression.

What evidence suggests that a prebiotic diet could be effective for melanoma?

Studies have shown that a diet rich in prebiotic foods (PreFED) can alter the gut bacteria mix, potentially enhancing immune system function. In melanoma, a type of skin cancer, the immune system plays a crucial role in combating cancer cells. Research suggests that PreFED could enhance the effectiveness of immune checkpoint blockade (ICB) therapy, which helps the immune system identify and attack cancer cells more efficiently. Early findings indicate that improving gut health with PreFED might increase this treatment's effectiveness. Participants in this trial will follow the Prebiotic food-enriched diet (PreFED) to assess its impact on immune function and treatment efficacy. ^{1 2 3 4 6}

Who Is on the Research Team?

Jennifer McQuade

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with melanoma that cannot be surgically removed and who are about to start immunotherapy. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I am starting my first standard immune therapy for advanced cancer, and it's been over 6 months since any previous similar treatments.

I am going back to MD Anderson for a cancer progress check.

English-speaking

Exclusion Criteria

Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting

I am currently taking more than 10 mg/day of Prednisone or its equivalent.

Medical contraindications to the Intervention Diet as determined by the treating physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a prebiotic food-enriched diet (PreFED) alongside immune checkpoint blockade (ICB) therapy

12 weeks

Regular visits for dietary counseling and monitoring

Maintenance

Participants continue with the dietary intervention to assess long-term effects and maintenance of response

12 weeks

Follow-up

Participants are monitored for safety, effectiveness, and long-term outcomes after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prebiotic food-enriched diet (PreFED)

Trial Overview The study is testing whether a diet enriched with prebiotic foods (PreFED) can improve the gut microbiome and enhance the effectiveness of first-line immunotherapy in treating unresectable melanoma.

How Is the Trial Designed?

Group I: Prebiotic food-enriched diet (PreFED) Experimental Treatment 1 Intervention

Participants will receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in the diet.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Inulin, a prebiotic, was found to significantly reduce harmful coliform bacteria and increase beneficial lactobacilli in the gut of rats, suggesting it can positively alter gut microbiota during colon cancer development.

The study showed that inulin supplementation decreased markers associated with inflammation and cancer progression, such as COX-2 and NFκB, indicating its potential as a chemopreventive agent against colon cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes chemopreventive markers in colorectal cancer development after inulin supplementation. Hijova, E., Szabadosova, V., Strojny, L., et al.[2023]

Camu camu (CC) appears to enhance the effectiveness of immune checkpoint inhibitors (ICIs) in patients with metastatic melanoma, as demonstrated by two case studies where patients achieved near complete responses after adding CC to their ICI treatment.

Both patients experienced durable responses for over a year with minimal immune-related adverse events, suggesting that CC may help modulate the gut microbiome to improve cancer treatment outcomes while reducing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two Cases of Durable and Deep Responses to Immune Checkpoint Inhibition-Refractory Metastatic Melanoma after Addition of Camu Camu Prebiotic. Pang, SA., Elkrief, A., Capella, MP., et al.[2023]

The BE GONE trial demonstrated that adding a daily cup of beans to the diet of obese patients with a history of colorectal neoplasia significantly increased gut microbiome diversity and levels of beneficial bacteria, indicating the prebiotic efficacy of beans.

The study also showed that this dietary intervention led to changes in circulating metabolites associated with gut health, although it did not significantly affect circulating lipoproteins within the 8-week period, highlighting the potential of beans in improving gut and metabolic health in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulating a prebiotic food source influences inflammation and immune-regulating gut microbes and metabolites: insights from the BE GONE trial. Zhang, X., Irajizad, E., Hoffman, KL., et al.[2023]

A diet-driven microbiome community can enhance the effectiveness of immune checkpoint inhibitors in melanoma patients, potentially improving treatment outcomes.

This research suggests that manipulating the diet to influence the microbiome may help reduce immune-related side effects during neoadjuvant therapy, opening new therapeutic possibilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross communication of diet-microbiome-immune interactions in cancer immunotherapy. Zhou, CB., Fang, JY.[2023]

Metastatic melanoma patients who achieved a complete and sustained response to immunotherapy showed significant differences in their gut microbiome composition, particularly with higher diversity and specific bacterial abundances, compared to those with early responses.

These late responders also had distinct dietary habits, including lower protein and sugar intake and higher flavonoid consumption, suggesting that both microbiome and diet may play a role in enhancing the effectiveness of immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the Gut Microbiome and Dietary Habits in Metastatic Melanoma Patients with a Complete and Sustained Response to Immunotherapy. Golčić, M., Simetić, L., Herceg, D., et al.[2023]

Prebiotics like inulin and mucin can enhance anti-tumor immune responses and inhibit melanoma growth in mice, but the presence of gut microbiota is essential for this effect, as shown by the lack of tumor inhibition in germ-free mice.

Inulin specifically not only limits tumor growth in various cancer models but also improves the effectiveness of a MEK inhibitor and helps delay drug resistance, highlighting its potential as a therapeutic strategy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotic-Induced Anti-tumor Immunity Attenuates Tumor Growth. Li, Y., Elmén, L., Segota, I., et al.[2022]

In a study comparing melanoma growth in mice with different gut microbiota, the presence of Bifidobacterium was linked to improved antitumor immunity, suggesting that gut bacteria can influence immune responses to tumors.

Oral administration of Bifidobacterium alone was as effective as PD-L1-specific antibody therapy in controlling tumor growth, and when combined, they nearly eliminated tumor outgrowth, indicating that modifying the microbiota could enhance cancer immunotherapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commensal Bifidobacterium promotes antitumor immunity and facilitates anti-PD-L1 efficacy. Sivan, A., Corrales, L., Hubert, N., et al.[2022]

The gut microbiome can predict the risk of developing immune-related adverse events (irAEs) in melanoma patients undergoing immune checkpoint blockade (ICB) therapy, with two distinct bacterial community clusters identified that show a nearly 7-fold difference in risk.

Specific bacterial strains, such as Bacteroides dorei in the high-risk group and Bacteroides vulgatus in the low-risk group, were linked to the likelihood of developing irAEs, suggesting that the gut microbiome composition may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacteroides vulgatus and Bacteroides dorei predict immune-related adverse events in immune checkpoint blockade treatment of metastatic melanoma. Usyk, M., Pandey, A., Hayes, RB., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06466434

NCT06466434 | Prebiotic Food-enriched Diet (PreFED) to ... To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting ...

2. reporter.nih.gov reporter.nih.gov/project-details/11167700

Project Details - NIH RePORTER ... prebiotic food enriched dietary intervention influences the gut microbiomeand response to immunotherapy in melanoma. Insights gained may have far-reaching ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06250335

NCT06250335 | Impact of a Prebiotic Food-enriched Diet ... To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with ICI-refractory melanoma who are ...

4. cancer.gov cancer.gov/clinicaltrials/NCI-2024-05150

Prebiotic Food-Enriched Diet to Enhance the Microbiome ... This clinical trial studies the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in patients with stage III-IV ...

5. trials.braintumor.org trials.braintumor.org/trials/NCT06250335

Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination ... To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with ICI-refractory melanoma who are ...

6. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/10939497

Prebiotic diet intervention to enhance the microbiome and ... Though our studies will focus on metastatic melanoma, dietary approaches to enhance the gut microbiome, anti-tumor immunity and ICI response are relevant and ...