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Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors

NCT06475807 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-14

No results posted yet for this study

Summary

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)

Conditions

Interventions

DIETARY_SUPPLEMENT

High-fermented food

Step 1: patients will consume high-fermented food

DIETARY_SUPPLEMENT

High fiber supplementation

Step 2: High fiber supplementation

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Hassane M Zarour, MD · UPMC Hillman Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06475807 on ClinicalTrials.gov