Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Pa… (NCT04645680) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic Melanoma Receiving Immunotherapy
United States50 participantsStarted 2020-06-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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