Cancer Nutrition Study: CaNS - A Pilot Study of Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
University of Pittsburgh
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)
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Be willing and able to provide written informed consent. 2. 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). 3. Patients must have any type of electronic device such as a smartphone, tablet, or computer etc that can access the internet. Body mass index (BMI) 18.5-40 kg/m2. 4. Self-reported willingness to adhere with dietary intervention. 5. Self-reported willingness to comply to scheduled follow ups, fil…
Interventions
- Dietary SupplementHigh-fermented food
Step 1: patients will consume high-fermented food
- Dietary SupplementHigh fiber supplementation
Step 2: High fiber supplementation
Location
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania