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

50 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Dietary Intervention, Nutritional Counseling, Dietary Therapy for melanoma?

Research shows that nutritional counseling and dietary interventions can improve the quality of life for cancer patients by addressing malnutrition and providing psychological support, which may help patients feel more in control and less isolated. ^{1 2 3 4 5}

Is the dietary intervention for melanoma safe for humans?

The research articles reviewed focus on the relationship between diet and melanoma risk, but they do not provide specific safety data for dietary interventions. Generally, dietary changes are considered safe, but individual components like high alcohol intake or certain supplements may have risks. It's important to consult with a healthcare provider before making significant dietary changes. ^{6 7 8 9 10}

How does the dietary intervention treatment for melanoma differ from other treatments?

The dietary intervention for melanoma focuses on nutritional counseling and dietary therapy, which is unique because it aims to improve the patient's overall nutritional status and well-being, rather than directly targeting the cancer itself. This approach is different from traditional treatments like surgery, chemotherapy, or radiation, as it emphasizes the role of nutrition in managing symptoms and potentially enhancing recovery. ^{5 11 12 13 14}

What is the purpose of this trial?

This phase II trial investigates the possible immune effects of two different diets targeting the gut microbiome in patients with stage III-IV melanoma that has been removed by surgery (resectable), has spread to other places in the body (metastatic), or is unable to be removed by surgery (unresectable), and who are being treated with the immunotherapy drugs pembrolizumab or nivolumab as part of their standard of care. Both diets are whole foods diets that meet the American Cancer Society recommendations for cancer patients, but they will vary in fiber content. 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 being treated with standard of care immunotherapy (pembrolizumab or nivolumab).

Research Team

Jennifer McQuade

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

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

Supportive nutrition to prevent cachexia and improve quality of life. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical aspects of nutrition in advanced cancer. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Nutrition in Cancer. [2015]

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

Optimizing nutrition for patients with cancer. [2013]

5. France pubmed.ncbi.nlm.nih.gov

[Nutritional workshops for cancer patients: a pilot approach]. [2019]

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

Diet and melanoma. An exploratory case-control study. [2019]

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

An Epidemiological Review of Diet and Cutaneous Malignant Melanoma. [2023]

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

Nutrition and melanoma prevention. [2022]

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

Diet and risk of cutaneous malignant melanoma: a prospective study of 50,757 Norwegian men and women. [2019]

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

Diet and melanoma in a case-control study. [2013]

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

The Pathways to Prevention program: nutrition as prevention for improved cancer outcomes. [2023]

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

Oral feeding in the nutritional management of the cancer patient. [2015]

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

Nutrition support in cancer. [2019]

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

Oral feedings in the cancer patient. [2019]