Dietary Intervention for Melanoma

(DIET Trial)

Overseen By Jennifer McQuade

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Immunotherapy

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

Disqualifiers: Colitis, Diabetes, Inflammatory bowel, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 11 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two different diets might affect the immune system in people with advanced melanoma, a type of skin cancer. Participants will follow one of two whole-food diets, which are similar but differ in fiber content, while receiving standard immunotherapy treatment. The goal is to determine if dietary changes can impact the gut microbiome and potentially improve treatment outcomes. Suitable candidates for this trial include those with advanced melanoma who are undergoing specific immunotherapy treatments and are willing to follow a special diet for the study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you must stop taking probiotics, fiber supplements, or any other medication or supplement that could affect the study outcome at least 14 days before starting the diet. Also, you cannot be on systemic corticosteroids or immunosuppressive medications within 14 days of the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dietary changes can aid in cancer treatment. Previous studies found that certain diets, like those in this trial, may lower the risk of some cancers, including colorectal and breast cancer. These studies also involved melanoma patients who followed specific diets while taking immunotherapy drugs such as pembrolizumab or nivolumab.

In one study, some patients experienced serious immune-related side effects, with 25% facing severe reactions. However, these side effects were linked to the immune system and not directly caused by the diet. This trial is in its second phase, indicating that earlier research demonstrated some level of safety.

Overall, while the high-fiber and whole foods diets being tested are usually well-tolerated, there remains a risk of immune-related side effects when combined with immunotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this dietary intervention for melanoma because it explores how a high-fiber diet might influence cancer outcomes. Unlike traditional treatments like surgery, chemotherapy, or immunotherapy that directly target cancer cells, this approach focuses on nutrition, aiming to boost the body's natural defenses and potentially improve treatment effectiveness. The unique aspect of this trial is its emphasis on an isocaloric high-fiber diet, which is thought to improve gut health and modulate the immune system, possibly leading to better patient responses to existing treatments. This innovative angle offers a non-invasive way to potentially enhance melanoma management and patient well-being.

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

Research shows that certain diets can affect how the immune system responds to melanoma, a type of skin cancer. Studies have found that a high-fiber diet can alter the gut microbiome, enhancing immune function. In this trial, participants in Arm I will receive an isocaloric high-fiber diet, which follows the recommended American Cancer Society guidelines but includes more fiber. One study discovered that high-fiber diets were linked to a stronger immune response in melanoma patients receiving immunotherapy. This suggests that increasing fiber intake might enhance the effectiveness of treatments like pembrolizumab or nivolumab. While more research is needed, these findings offer hope that dietary changes could aid cancer treatment. ^{1 2 6 7 8}

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 adults over 18 with stage III-IV melanoma, either removed surgically or not resectable, who are starting immunotherapy. Participants must have a BMI of 18.5-40, be in good physical condition (ECOG status 0 or 1), speak English, and commit to eating specific diets and providing samples. Exclusions include certain medical conditions like colitis, heavy drinking/smoking/drug use, recent antibiotic/probiotic use, high fiber intake or major dietary restrictions.

Inclusion Criteria

Criterion Summary: 1. Participants with resected stage II-IV melanoma planning to start adjuvant anti-PD1 +/- anti-CTLA4 or anti-LAG3 treatment are eligible. 2. Participants with unresectable stage III or IV melanoma planning to start standard anti-PD1 +/- CTLA4 or anti-PD1 +/- LAG3 treatment and no prior immunotherapy for metastatic disease are eligible. 3. Participants with stage III/IV melanoma planning to start neoadjuvant anti-PD1 +/- anti-CTLA4 or anti-LAG3 treatment are eligible, and they must have available archival tissue or be willing to undergo a baseline biopsy. 4. Participants with unresectable clear-cell renal cell carcinoma planning to start standard anti-PD1 +/- anti-CTLA4 treatment are eligible.

English-speaking

Self-reported willingness to exclusively eat the provided diets

Exclusion Criteria

You have a history of severe colitis or diarrhea while on immunotherapy, or you currently have any level of colitis or diarrhea.

Uncontrolled concurrent illness or infection or psychiatric illness/social situations that would limit compliance with study requirements

Regularly taking probiotics, fiber supplements, or any other medication or supplement that could affect study outcome as determined by the principal investigator and unable/unwilling to discontinue for the purpose of the study. These agents must be discontinued at least 14 days prior to start of diet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a high-fiber or control whole foods diet for 11 weeks

11 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Intervention

Trial Overview The DIET study tests the immune effects of two whole food diets differing in fiber content on patients with advanced melanoma undergoing standard immunotherapy treatments pembrolizumab or nivolumab. The goal is to understand how diet influences the gut microbiome's structure and function during immunotherapy.

How Is the Trial Designed?

Group I: Arm I (isocaloric high-fiber diet) Experimental Treatment 3 Interventions

Patients receive a whole foods diet that follows the recommended American Cancer Society guidelines but is higher in fiber for 11 weeks.

Group II: Arm II (isocaloric diet) Active Control 3 Interventions

Patients receive a standard whole foods diet recommended by the American Cancer Society for 11 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Nutritional therapy for cancer patients focuses on managing factors like taste changes, pain, nausea, and depression that can lead to loss of appetite, and includes education on eating behaviors and the use of nutritional supplements.

Patients showed a preference for milk-based nutritional supplements over synthetic products, suggesting that understanding patient preferences can help healthcare teams choose the most acceptable and effective nutritional support for individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral feeding in the nutritional management of the cancer patient. De Wyes, WD., Herbst, SH.[2015]

A workshop by the National Institutes of Health highlighted the need for baseline screening for malnutrition risk in cancer patients, recommending that this screening be repeated during and after treatment to ensure proper nutritional support.

Current evidence shows that while nutritional interventions may help reduce malnutrition-related issues in cancer patients, many studies are of low quality and inconsistent, indicating a strong need for more rigorous research to determine their true effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pathways to Prevention program: nutrition as prevention for improved cancer outcomes. Hiatt, RA., Clayton, MF., Collins, KK., et al.[2023]

Clinicians have a variety of nutrition intervention strategies to support cancer patients facing malnutrition, emphasizing the need for tailored approaches based on individual assessments.

Oncology nurses play a crucial role in monitoring patients' nutritional status and implementing timely interventions, highlighting the importance of their knowledge in nutrition support throughout the cancer treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition support in cancer. Bloch, A.[2019]

Malnutrition is a critical issue for cancer patients, significantly affecting their response to treatment and overall survival, highlighting the need for early nutritional intervention.

The CANCER acronym serves as a guide for developing a comprehensive nutritional plan tailored to individual patient needs, emphasizing the importance of ongoing evaluation and adjustment of nutritional support throughout treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing nutrition for patients with cancer. Wilson, RL.[2013]

Maintaining proper nutrition is crucial for cancer patients, as it supports their overall health and treatment effectiveness; the oncology team must understand factors affecting food acceptance to provide suitable dietary options.

Oral feeding is preferred, and nutritional supplements can help ensure adequate intake, but in cases of severe side effects like nausea or mucositis, intravenous feeding may be necessary to prevent malnutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral feedings in the cancer patient. Aker, SN.[2019]

A study of 41 women with melanoma compared to 297 controls found that high intakes of polyunsaturated fatty acids were strongly associated with a reduced risk of melanoma, suggesting a potential protective effect.

Women consuming 20 grams or more of alcohol daily had a significantly increased risk of melanoma, with an odds ratio of 2.5, indicating that alcohol consumption may be a risk factor for this type of skin cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and melanoma. An exploratory case-control study. Bain, C., Green, A., Siskind, V., et al.[2019]

Epidemiological studies suggest that dietary factors, such as caffeine, may lower the risk of developing cutaneous malignant melanoma, while citrus fruits and alcohol are linked to an increased risk.

The review highlights the potential mechanisms by which diet influences melanoma development, including enhancing UV-induced cell death and altering photosensitivity, indicating that dietary modifications could play a role in public health strategies to reduce melanoma incidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Epidemiological Review of Diet and Cutaneous Malignant Melanoma. Yang, K., Fung, TT., Nan, H.[2023]

A 3-year nutritional workshop for cancer patients, involving 56 participants (91% women), provided valuable information on nutrition and psychosocial support, helping to address the psychological and nutritional challenges faced by these patients.

The workshops, which included diet education and supportive group sessions, were believed to enhance social reintegration and emotional expression, indicating their potential benefit in humanizing cancer treatment, although the current evaluation is subjective and a more systematic study is underway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutritional workshops for cancer patients: a pilot approach]. Mouysset, JL., Baciuchka-Palmaro, M., Ichou, M., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11619607/

a randomized, double-blinded dietary intervention study in ... This is a randomized, double-blind, fully controlled feeding study that will enroll 45 melanoma patients starting standard-of-care (SOC) ICB in three settings.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04645680

NCT04645680 | Effect of Diet on the Immune System in ... The purpose of this trial is to learn about the effects of dietary interventions on the structure and function of the gut microbiome in patients with melanoma ...

3. withpower.com withpower.com/trial/phase-3-melanoma-5-2020-00030

Dietary Intervention for Melanoma (DIET Trial) The research articles reviewed focus on the relationship between diet and melanoma risk, but they do not provide specific safety data for dietary interventions.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.9511

A randomized controlled phase 2 trial of a high fiber diet ... We conducted a proof-of-principal randomized trial of a fully controlled feeding study comparing HFDI with healthy control diet in melanoma ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8624488/

Nutritional Interventions for Patients with Melanoma Several studies have demonstrated the impact of dietary attitudes, specific foods, and nutrients both on the risk for melanoma and on the progression of the ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.9558

The DIET study: A randomized controlled trial of a high ... The rate of Grade III/IV immune related adverse events was 25%. Conclusions: In this fully-controlled feeding study among melanoma pts ...

7. mdpi.com mdpi.com/2072-6643/17/11/1891

The Influence of Dietary Factors on Melanoma ... Dietary modifications have been associated with a reduced risk of other malignancies, such as colorectal and breast cancer. However, evidence linking diet to ...

8. mdanderson.org mdanderson.org/cancerwise/nutrivention-food-as-medicine.h00-159776445.html

Nutrivention: Food as medicine The DIET study is a proof-of-concept study that suggests that a high fiber diet can be used to improve immunotherapy outcomes in patients undergoing treatment ...