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)
Several studies have shown that diet can modulate the gut microbiome and affect the biology of the immune system. The role of the high-fermented food diet and high-fiber supplementation on gut microbiome in patients with cancer treated with immunotherapy will be evaluated. Fermented diet and high-fiber supplementation rational: a high-fermented food diet promotes gut microbiome composition and lowers systemic inflammatory markers. Additionally, high fiber diet may be associated with improved clinical outcomes in immune checkpoint inhibitor treated cancer patients. The effect of high-fermented food and high-fiber supplementation on gut microbiome and systemic inflammation in patients with cancer will be examined. The results of this study will be used to help to design future dietary intervention trials in cancer patients receiving immunotherapy. Baseline diet information, stool and blood samples will be collected. Patients initially receive high-fermented food diet for 4 weeks, followed by 2-week break/observation period and then cross over to high-fiber supplementation for another 4 weeks, followed by 2 weeks break/observation period. During break/observation period patients can eat any type of food, without dietary restrictions. During the dietary intervention period 24-hour dietary recall information will be collected, stool samples weekly and blood sample every 2-4 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
70
Step 1: patients will consume high-fermented food
Step 2: High fiber supplementation
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RECRUITINGChange 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 weeks
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 weeks
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 weeks
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