NCT06475807

Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors

Cancer Nutrition Study: CaNS - A Pilot Study of Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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 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.

Conditions

• Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High-fermented food	Step 1: patients will consume high-fermented food
DIETARY_SUPPLEMENT	High fiber supplementation	Step 2: High fiber supplementation

Timeline

• Start date: 2024-07-17
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-06-26
• Last updated: 2025-05-14

Locations

1 site across 1 country: United States