Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438588
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-22
Brief Title:
Fasting Mimicking Diet for Reducing Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors FMD-ICI Trial
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Effect of Fasting Mimicking Diet FMD on Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors The FMD-ICI Feasibility Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
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 clinical trial assesses an effective and translatable care model to understand and reduce the adverse effects that cancer patients experience during their treatment therapies and thereby enhance their well-being and quality of life Excessive immune activation can affect multiple organs with the most common adverse effects being skin rash diarrhea colitis fatigue hypothyroidism and anorexia A restrictive calorie diet mostly of fat and complex carbohydrates will mimic fasting and increase resiliency to protect patients from the adverse effects of cancer treatments by managing the adverse side effects of immune checkpoint inhibitors ICI treatments in select cancer patients The fast mimicking diet FMD Xentigen is a calorie restrictive low-calorie low-protein high complex carbohydrate high-fat diet The FMD program is a plant-based diet program designed to attain fasting-like effects while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects The FMD consists of 100 ingredients which are generally regarded as safe GRAS and comprises mainly of vegetable-based soups and broths energy bars energy drinks cracker snacks herbal teas and supplements Following a FMD may reduce the adverse effects that some cancer patients experience while following immunotherapy treatments
Detailed Description:
PRIMARY OBJECTIVES
I Assess the impact of immunotherapy FMDXentigen on immune related adverse events rates irAEs including immune-mediated colitis
II Appraise the impact of immunotherapy FMDXentigen on the patients physical function and quality of life
III Evaluate the impact of immunotherapy FMDXentigen on surrogate markers of inflammation ie fecal calprotectin as a predictive marker of immune-mediated colitis
OUTLINE
Patients receive nutrition counseling with a nutritionist over 60 minutes receive FMD over 4 days for 3 cycles of immunotherapy and educational guidelines for day 5 to transition to a regular diet Patients undergo blood sample collection throughout the study
Upon completion of study intervention patients are followed up at 6 months
I Assess the impact of immunotherapy FMDXentigen on immune related adverse events rates irAEs including immune-mediated colitis
II Appraise the impact of immunotherapy FMDXentigen on the patients physical function and quality of life
III Evaluate the impact of immunotherapy FMDXentigen on surrogate markers of inflammation ie fecal calprotectin as a predictive marker of immune-mediated colitis
OUTLINE
Patients receive nutrition counseling with a nutritionist over 60 minutes receive FMD over 4 days for 3 cycles of immunotherapy and educational guidelines for day 5 to transition to a regular diet Patients undergo blood sample collection throughout the study
Upon completion of study intervention patients are followed up at 6 months
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03515 | REGISTRY | None | None |
| 20-012936 | OTHER | Mayo Clinic Institutional Review Board | None |