This clinical trial tests whether eating high levels of fiber and fermented foods can improve gut microbiome in patients with stage IIB-IIIC melanoma and stage IB-IIIC non-small cell lung cancer (NSCLC) who are being treated with immunotherapy using drugs called immune checkpoint inhibitors (ICI). The gut microbiome is the collection of microorganisms (like bacteria) that are live in the digestive system and are involved in various body functions such as metabolizing (breaking down) substances in food and drugs and controlling immune function. Modifiable factors such as dietary interventions, including increased high-fiber supplementation and high-fermented food intake, may reduce inflammation and modulate (regulate) the immune system. High-fermented food includes kefir, kombucha, buttermilk, sauerkraut, kimchi, and vegetable brine drinks. Resistant starches are complex carbohydrates that, similarly to fiber, are not fully digested by the human gut and undergo fermentation (dissolving) by gut microbiota in the colon, where several healthy nutrients are produced. Resistant starches have been linked to a healthy and beneficial gut microbiome. High-amylose resistant starch, HI-MAIZE 260, is digestible and can be consumed raw and mixed with water, beverages, soups, or fruit purees. Diets high in fiber and fermented foods may improve gut microbiome in patients with stage IIB-IIIC melanoma and stage IB-IIIC NSCLC.
Additional locations may be listed on ClinicalTrials.gov for NCT06475807.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Contact: Hassane M. Zarour
Phone: 412-623-3272
PRIMARY OBJECTIVE:
I. To longitudinally assess the gut microbiota composition, diversity, and function in cancer patients with dietary modification (sequential use of high-fermented food and high fiber supplementation) treated with PD-1/PD-L1 Inhibitors.
SECONDARY OBJECTIVES:
I. To determine the tolerability and safety of dietary modification (high-fermented food and high fiber supplementation), in patients on anti-PD-1/PD-L1 therapy and assess effects on treatment response and the frequency immune‐related adverse events (irAEs).
II. To identify the changes (frequency, phenotype, and function) of host circulating innate and adaptive immune cells, circulating inflammatory cytokines and metabolites related to dietary modification (high-fermented food and high fiber supplementation) in cancer patients treated with PD-1/PD-L1 Inhibitors.
EXPLORATORY OBJECTIVES:
I. To determine tolerability of dietary intervention determined by patient-reported gastrointestinal symptoms.
II. The number of patients who adhere to dietary modification during the dietary intervention period.
III. To assess the association between baseline physical activity and the gut microbiome.
OUTLINE:
STEP 1: Patients consume high-fermented food daily for 4 weeks. Patients then have the option to continue the assigned diet or a diet of their choice for 2 weeks.
STEP 2: Beginning at week 7, patients consume high-fiber supplement with high-amylose resistant starch (HI-MAIZE 260) daily for 4 weeks.
All patients also undergo blood sample collection throughout the study.
After completion of study intervention, patients are followed up at 14 weeks then for 1 year.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorHassane M. Zarour