NCT04645680

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: To establish the effects of dietary intervention on the structure and function of the gut microbiome. SECONDARY OBJECTIVES: 1. Assess the effects of dietary intervention on gut metabolic output and systemic metabolism. 2. Assess the effects of dietary intervention on systemic and tumor immunity 3. Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention 4. Assess the rate of immune related adverse events in patients on immunotherapy receiving dietary interventions 5. Determine the maximum daily fiber content that 70% of participants are able to tolerate 6. 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) 7. Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs) EXPLORATORY OBJECTIVES: 1. 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). 2. 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.

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

Interventions

Type	Name	Description
OTHER	Dietary Intervention	Consume isocaloric whole foods diet higher in fiber
OTHER	Dietary Intervention	Whole foods diet
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-06-24
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2020-11-27
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States