Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic Melanoma Receiving Immunotherapy

NCT04645680 | Active Not Recruiting Phase 2

• 3 other identifiers: 2020-0158 (PA17-0104)NCI-2020-061122020-0158
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, fully controlled feeding study that will enroll melanoma patients starting standard-of-care ICB in three settings: adjuvant, neoadjuvant, and unresectable. Patients are randomized to the high fiber or healthy control diet. The goal of the study is to establish the effects of dietary intervention on the structure and function of the gut microbiome in patients with melanoma treated with SOC immunotherapies.

Conditions

Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Melanoma; Pathologic Stage III Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8; Unresectable Melanoma; Stage II Melanoma; Uveal Melanoma; Mucosal Melanoma; Unresectable Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Change in the gut microbiome

  Changes of alpha-diversity (e.g., Shannon index) and abundance/relative abundance of different taxon levels (e.g., genus, family), from baseline to end of intervention, will be estimated. The outcomes will be compared. between two arms using t-test or Mann-Whitney test. Linear mixed effects models will be used for assessing the longitudinal data. Similarity in microbiome community structure will be assessed using principal coordinate analysis (PCoA) and compared using multivariate analysis of variance (MANOVA).

  Baseline up to 11 weeks

Secondary Outcomes (5)

• Change in systemic and tumor immunity

  Up to 12 weeks

• Change in metabolic profile

  Baseline up to 11 weeks

• Change in quality of life (QOL)

  Baseline up to 11 weeks

• Incidence of adverse events

  Up to 12 weeks

• Symptom profile

  Up to 12-week follow-up

Other Outcomes (3)

• Objective response rate (ORR) (unresectable cohort)

  At 12-week follow-up

• Progression-free survival (PFS) (unresectable cohort)

  Up to 12-week follow-up

• Recurrence rate (RR) (adjuvant cohort)

  Up to 12-week follow-up

Study Arms (2)

Arm I (isocaloric high-fiber diet)

EXPERIMENTAL

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

Other: Dietary Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (isocaloric diet)

ACTIVE COMPARATOR

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

Other: Dietary Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Dietary Intervention OTHER

Consume isocaloric whole foods diet higher in fiber

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Arm I (isocaloric high-fiber diet)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (isocaloric high-fiber diet); Arm II (isocaloric diet)

Questionnaire Administration OTHER

Ancillary studies

Arm I (isocaloric high-fiber diet); Arm II (isocaloric diet)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Body mass index (BMI) 18.5-40 kg/m\^2
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• English-speaking
• Self-reported willingness to exclusively eat the provided diets
• Self-reported willingness to comply with scheduled visits, undergo venipuncture, and provide stool samples
• Cohort-specific:
• Adjuvant Melanoma: i. Resected Stage II-IV melanoma with planned initiation of adjuvant anti-PD1 +/- anti-CTLA4 or anti-LAG3
• Unresectable Melanoma: i. Histologically confirmed unresectable stage III or Stage IV melanoma with planned initiation of standard of care anti-PD1 +/- CTLA4 or anti-PD1 +/- LAG3 immunotherapy and no prior immunotherapy in the metastatic setting.
• Neoadjuvant Melanoma: i. Histologically confirmed stage III/IV melanoma with planned initiation of neoadjuvant anti-PD1 +/- anti-CTLA4 or anti-LAG3 1. Participants must have archival tissue block available or be willing to undergo a newly-obtained core needle or incisional biopsy at baseline. Fine needle aspiration is not acceptable.
• Unresectable RCC: i. Unresectable clear-cell renal cell carcinoma with planned initiation of standard of care anti-PD1 +/- anti-CTLA4 immunotherapy

You may not qualify if:

• History of \>= grade II colitis or diarrhea on immunotherapy or any ongoing colitis or diarrhea of any grade
• Unresolved \>= grade III immune-related adverse event on immunotherapy (other than endocrinopathy requiring hormone replacement)
• History of active inflammatory bowel disease or major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment or any history of total colectomy, or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e. restrictive procedures such as banding, are permitted).
• Medical contraindications to intervention diet as determined by the treating physician
• Self-reported major dietary restrictions related to the intervention
• Diagnosis of diabetes mellitus type I or type II that requires medical treatment or random glucose \> 200 mg/dL
• Antibiotic use within 21 days of planned start of equilibration diet (self-reported and/or noted by the treating physician)
• Has a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study intervention administration. Inhaled or topical steroids, and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
• 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
• Currently consuming an average estimated daily fiber intake exceeding 20 grams based on the results of the preliminary dietary assessment; vegetarian or vegan
• Current smoker or heavy drinker (defined as \> 14 drinks per week) or current self reported illicit drug use
• Uncontrolled concurrent illness or infection or psychiatric illness/social situations that would limit compliance with study requirements
• Unable or unwilling to undergo study procedures
• Plan for travel during the study that would preclude adherence to prescribed diets
• Cognitively impaired adults

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Farias RM, Jiang Y, Levy EJ, Hwang C, Wang J, Burton EM, Cohen L, Ajami N, Wargo JA, Daniel CR, McQuade JL. Diet and Immune Effects Trial (DIET)- a randomized, double-blinded dietary intervention study in patients with melanoma receiving immunotherapy. BMC Cancer. 2024 Dec 4;24(1):1493. doi: 10.1186/s12885-024-13234-1.

  PMID: 39633321 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Melanoma; Uveal Melanoma

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Erez Baruch, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be blinded to their assigned diet throughout the intervention as will the investigators and research staff with the exception of the dietitian and the staff performing group assignment and data entry who will not have contact with participant
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: November 27, 2020
• Study Start: June 24, 2020
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

US (1)