Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- University of Pittsburgh
- Study ID
- NCT06475807
- Status
- Recruiting
Conditions
- Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- High-fermented food — DIETARY_SUPPLEMENTStep 1: patients will consume high-fermented food
- High fiber supplementation — DIETARY_SUPPLEMENTStep 2: High fiber supplementation
Study Details
This pilot trial will study the potential impact of two distinct dietary interventions with sequential use of high-fermented foods and high-fiber supplements on the gut microbiome and antitumor immunity in patients with melanoma and non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors. The trial aims to understand how dietary changes affect the composition and function of the gut microbiome, together with immunological and metabolomic markers in serum in patients with melanoma and NSCLC who are undergoing standard-of-care treatment with a PD-1/PD-L1 Inhibitors (neoadjuvant, adjuvant or consolidation)
Key Dates
- Start date
- Jul 17, 2024
- Status verified
- Mar 2026
- Primary completion
- Jun 30, 2030
- Completion
- Jun 30, 2030
Study Design
- Enrollment
- 70 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: high-fermented food + high fiber supplementationStep 1: patients will consume high-fermented food Step 2: High fiber supplementation
Primary Outcome Measure
Change in cell frequency of gut microbiota composition [ Time Frame: Up to 14 weeks ]
Central Contacts
- Hassane M Zarour, MD(412) 623-3272
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 |
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