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
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients undergoing immunotherapy regardless of prior immunotherapy history

• Age ≥ 18 years

• Body mass index (BMI) \> 19

• Histological confirmation of advanced staged malignancies (stage 3 or 4) appropriate for the following types of immunotherapy: PD-1 Antibody (nivolumab, pembrolizumab), PD-L1 Antibody (atezolizumab, avelumab, durvalumab), CTLA-4 Antibody (ipilimumab) or any combination thereof

Locations
United States
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2024-03-06
Estimated Completion Date: 2027-03-15
Participants
Target number of participants: 10
Treatments
Experimental: Supportive Care (FMD)
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.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov