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Dietary Intervention for Melanoma (DIET Trial)
Phase 2
Recruiting
Led By Jennifer McQuade
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
DIET Trial Summary
This trial is investigating the effects of two different diets on the gut microbiome of patients with stage III-IV melanoma.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on dietary interventions rather than drugs, side effects may be minimal compared to medication-based trials. However, changes in diet can sometimes cause gastrointestinal discomfort such as bloating or changes in bowel habits.
DIET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the gut microbiome
Secondary outcome measures
Change in metabolic profile
Change in quality of life (QOL)
Change in systemic and tumor immunity
+2 moreOther outcome measures
Objective response rate (ORR) (unresectable cohort)
Progression-free survival (PFS) (unresectable cohort)
Recurrence rate (RR) (adjuvant cohort)
DIET Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (isocaloric high-fiber diet)Experimental Treatment3 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 Control3 Interventions
Patients receive a standard whole foods diet recommended by the American Cancer Society for 11 weeks.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,275 Total Patients Enrolled
103 Trials studying Melanoma
25,524 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,687 Total Patients Enrolled
559 Trials studying Melanoma
195,400 Patients Enrolled for Melanoma
Jennifer McQuadePrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Melanoma
20 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of severe colitis or diarrhea while on immunotherapy, or you currently have any level of colitis or diarrhea.You eat a lot of fiber every day, and you follow a vegetarian or vegan diet.You currently smoke, drink heavily (more than 14 drinks per week), or use illegal drugs.You are currently taking strong medications that weaken your immune system, like corticosteroids, or other drugs that suppress your immune system.You have had major surgery on your stomach or intestines within the last 3 months, or have a history of certain types of stomach or bowel diseases.You have strict dietary rules that could affect the study intervention.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.Your body mass index (BMI) is between 18.5 and 40.You are able to carry out everyday activities without limitations or with minimal limitations due to your health.You have a severe immune-related side effect from a previous immunotherapy treatment that has not been fully resolved.You have type I or type II diabetes that needs medication, or your random glucose level is higher than 200 mg/dL.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (isocaloric high-fiber diet)
- Group 2: Arm II (isocaloric diet)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current scope of subjects participating in this experiment?
"Affirmative. The clinicaltrial.gov site shows that this research is still actively recruiting participants, having been put up on June 24th 2020 and updated as recently as September 21st 2022. 42 patients are needed from one location for the trial to be successful."
Answered by AI
To what degree can Dietary Intervention be considered hazardous for patients?
"The safety rating of dietary intervention is a 2, as there exists some data that indicates its safeness but no proof of efficacy."
Answered by AI
Are there open slots for participants in this investigation?
"Evidently, the search for study participants is ongoing as per clinicaltrials.gov's records which indicate that this trial was first posted on June 24th 2020 and last updated on September 21st 2022."
Answered by AI
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