Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475807
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-04
Brief Title:
Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Cancer Nutrition Study CaNS - A Pilot Study of Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 neoadjuvant or adjuvant immune checkpoint inhibitors
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 breakobservation period and then cross over to high-fiber supplementation for another 4 weeks followed by 2 weeks breakobservation period During breakobservation 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None