Effect of Diet on the Immune System in Patients With Stage III-IV Melanoma Receiving Immunotherapy, DIET Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- 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
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Masking Description: 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 participantPrimary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To establish the effects of dietary intervention on the structure and function of the gut microbiome. SECONDARY OBJECTIVES: I. Assess the effects of dietary intervention on gut metabolic output and systemic metabolism. II. Assess the effects of dietary intervention on systemic ...
PRIMARY OBJECTIVE: I. To establish the effects of dietary intervention on the structure and function of the gut microbiome. SECONDARY OBJECTIVES: I. Assess the effects of dietary intervention on gut metabolic output and systemic metabolism. II. Assess the effects of dietary intervention on systemic and tumor immunity. III. Determine the safety (adverse events [AEs]) and tolerability (Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome [GSRS-IBS]) of the dietary intervention. IV. Assess the rate of immune related adverse events in patients on immunotherapy receiving dietary interventions. V. Determine the maximum daily fiber content that 70% of participants are able to tolerate. VI. Assess the adherence to the dietary interventions as defined by 70% of calories consumed over the duration of the study being derived from provided diets (as measured by food records). VII. Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs). EXPLORATORY OBJECTIVES: I. Assess the association of dietary interventions with clinical outcomes (objective response rate [ORR] and progression-free survival [PFS] rate in unresectable cohort and recurrence rate [RR] in adjuvant cohort). II. Explore predictors of biological response to dietary interventions. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (ISOCALORIC HIGH-FIBER DIET): Patients receive a whole foods diet that follows the recommended American Cancer Society guidelines but is higher in fiber for 11 weeks. ARM II (ISOCALORIC CONTROL DIET): Patients receive a standard whole foods diet of recommended by the American Cancer Society for 11 weeks. After completion of study, patients are followed up at 12 weeks.
Tracking Information
- NCT #
- NCT04645680
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Jennifer McQuade M.D. Anderson Cancer Center
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