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

Trial Summary

What is the purpose of this trial?

To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.

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 data supports the effectiveness of the treatment Prebiotic food-enriched diet (PreFED) for melanoma?

Research shows that certain prebiotics, like inulin and mucin, can enhance the body's immune response against tumors in mice, slowing the growth of melanoma. Additionally, a prebiotic called camu camu has helped patients with melanoma respond better to existing treatments, suggesting that prebiotics can improve cancer treatment by positively affecting gut bacteria. ^{1 2 3 4 5}

Is the prebiotic diet safe for humans?

Research suggests that prebiotics, like inulin, are generally safe and can positively influence gut health and immune responses, although specific safety data for humans in the context of melanoma is not detailed in the available studies. ^{1 3 6 7 8}

How is the Prebiotic Diet for Melanoma treatment different from other treatments for melanoma?

The Prebiotic Diet for Melanoma is unique because it targets the gut microbiome (the community of microorganisms in the digestive tract) to enhance the body's immune response against tumors. Unlike traditional treatments, this diet uses prebiotics like inulin to promote beneficial bacteria that can improve the effectiveness of existing cancer therapies and potentially reduce tumor growth. ^{1 2 3 4 5}

Research Team

Jennifer McQuade

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prebiotic-Induced Anti-tumor Immunity Attenuates Tumor Growth. [2022]

2. Switzerland 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Commensal Bifidobacterium promotes antitumor immunity and facilitates anti-PD-L1 efficacy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cross communication of diet-microbiome-immune interactions in cancer immunotherapy. [2023]

5. Switzerland 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Bacteroides vulgatus and Bacteroides dorei predict immune-related adverse events in immune checkpoint blockade treatment of metastatic melanoma. [2022]

7. Slovakia pubmed.ncbi.nlm.nih.gov

Changes chemopreventive markers in colorectal cancer development after inulin supplementation. [2023]

8. Netherlands 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. [2023]