Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466434
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-14
Brief Title:
Prebiotic Food-enriched Diet PreFED to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Prebiotic Food-enriched Diet PreFED to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
Status:
RECRUITING
Status Verified Date:
2024-07
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:
To learn about the possible effects of a prebiotic food-enriched diet PreFED targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade ICB therapy
Detailed Description:
Primary Objectives
Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline to 12 weeks
Secondary Objectives
Determine the best overall response rate BORR to PreFED ICB regimens and landmark ORR at 12 weeks intervention and 24 weeks maintenance
Determine progression-free survival PFS and overall survival OS with PreFED ICB regimens
Compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks
Determine the safety diet-related AEs and tolerability GSRS-IBS of the dietary intervention at 12 weeks and maintenance at 24 weeks
Assess the rate of immune related adverse events in patients on ICB regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks
Assess the effects of dietary intervention on systemic and tumor immunity
Assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks
Assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks
Assess the effects of dietary interventions on quality of life and other patient reported outcomes PROs at 12 weeks and maintenance at 24 weeks
Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline to 12 weeks
Secondary Objectives
Determine the best overall response rate BORR to PreFED ICB regimens and landmark ORR at 12 weeks intervention and 24 weeks maintenance
Determine progression-free survival PFS and overall survival OS with PreFED ICB regimens
Compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks
Determine the safety diet-related AEs and tolerability GSRS-IBS of the dietary intervention at 12 weeks and maintenance at 24 weeks
Assess the rate of immune related adverse events in patients on ICB regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks
Assess the effects of dietary intervention on systemic and tumor immunity
Assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks
Assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks
Assess the effects of dietary interventions on quality of life and other patient reported outcomes PROs at 12 weeks and maintenance at 24 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-05150 | OTHER | None | None |