Actively Recruiting
Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
Led by University of Pittsburgh · Updated on 2025-05-14
60
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older willing to provide informed consent.
- Able to provide blood and stool samples and comply with dietary changes.
- Have access to an electronic device with internet.
- Body mass index between 18.5 and 40 kg/m2.
- Willing to follow the dietary plan and complete questionnaires and food logs.
- Patients receiving or starting standard care anti-PD-1/PD-L1 therapy for melanoma or non-small cell lung cancer at specified stages.
- Melanoma patients in clinical trials receiving standard care immunotherapy.
- Patients with single metastatic or recurrent melanoma lesions post-surgery receiving adjuvant immunotherapy.
- NSCLC patients in clinical trials receiving standard care immunotherapy after tumor resection or consolidation therapy.
You will not qualify if you...
- Patients in clinical trials receiving experimental immune checkpoint inhibitor treatments.
- Use of systemic antibiotics, antifungals, antivirals, antiparasitics within 4 weeks before the study.
- Recent use of corticosteroids over 10 mg prednisone equivalents or other immunosuppressive drugs within 14 days before intervention.
- Use of cytokines, methotrexate, or immunosuppressive cytotoxic agents.
- Regular use of probiotics, fiber supplements, or other dietary supplements affecting gut microbiome without willingness to stop 14 days before diet.
- Chronic alcohol use exceeding specified amounts in the last 4 weeks.
- Current high intake of fiber or fermented foods exceeding study limits.
- History of major bowel surgery.
- Medical reasons preventing diet participation as judged by physician.
- Use of systemic antibiotics or proton pump inhibitors during study unless discontinued 21 days prior.
- Inability or unwillingness to follow study schedules and procedures.
- History of active uncontrolled gastrointestinal diseases including inflammatory bowel disease, malabsorption, infectious gastroenteritis, colitis, gastritis, chronic diarrhea, or untreated infections like Clostridium difficile or Helicobacter pylori.
AI-Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
H
Hassane M Zarour, MD
CONTACT
K
Khvaramze Shaverdashvili, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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