🏛️ Verified NIH Record • Updated 2026-01-28
Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic Melanoma Receiving Immunotherapy (NCT04645680)
🔵 Active, Not Recruiting Phase2 📋 Clinical Research Protocol Sponsor: M.D. Anderson Cancer Center
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: M D Anderson Cancer Center — Houston, Texas
Age range: 18 Years
🧪 Interventions in This Study
- Dietary Intervention (OTHER)
- Dietary Intervention (OTHER)
- Quality-of-Life Assessment (OTHER)
- Questionnaire Administration (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- M D Anderson Cancer Center — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Clinical Stage III Cutaneous Melanoma AJCC v8
- Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma — Houston, Texas
- A Phase II Trial of PD-L1 Therapy Combined With Anti-VEGF Therapy in Unresectable or Metastatic Melanoma — Boston, Massachusetts
- Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors — Nashville, Tennessee
- Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors — Houston, Texas
- A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma — Anchorage, Alaska
Explore by condition: All Clinical Stage III Cutaneous Melanoma AJCC v8 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.