Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be willing and able to provide written informed consent.
Adult ≥ 18 years of age, willing and able to provide blood and stool specimen and comply with dietary modification, as well as willing to fill out study required questionnaires (paper or electronic and web-based).
Patients must have any type of electronic device such as a smartphone, tablet, or computer etc that can access the internet.
Self-reported willingness to adhere with dietary intervention.
Disqualifiers
Patients receiving ICIs enrolled in a clinical trial in the experimental arm.
Systemic antibiotics, antifungals, antivirals, or antiparasitics (intravenous, intramuscular, or oral);
Oral, intravenous, intramuscular, nasal, or inhaled 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)
Cytokines.
Trial design
Design model
Single group
Treatments tested in this trial
High-fermented food
Dietary supplementStep 1: patients will consume high-fermented food
High fiber supplementation
Dietary supplementStep 2: High fiber supplementation
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: high-fermented food + high fiber supplementationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in cell frequency of gut microbiota composition
Changes in gut microbiome diversity and function, evaluated with metagenomics, identify differentially abundant taxa and assess all genes in all organisms present in each fecal microbiota sample in pre- vs. post- each dietary using PERMANOVA. This will be measured as change of cell frequency and calculated as percentage change.
Time frame
Up to 14 weeksSecondary outcomes
1
Adverse Events and Serious Adverse Events
Incidence of anti-PD-1/PD-L1 therapy treatment-related grade 3 or more toxicities per CTCAE v5.0
Time frame
Up to 14 weeks2
Changes in cell frequency of circulating adaptive immune cells
Changes in the circulating adaptive and innate cells in the systemic circulation, evaluated with multiparameter flow cytometry, peripheral blood mononuclear cells will be used to evaluate cell frequency, phenotype, and function. This will be measured as change of cell frequency and calculated as percentage change.
Time frame
Up to 14 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov