Fasting Mimicking Diet to Reduce Side Effects in Cancer Patients on Immunotherapy
Effect of Fasting Mimicking Diet (FMD) on Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors: The FMD-ICI Feasibility Pilot Study
This study tests if a special diet that mimics fasting can help cancer patients on immunotherapy feel better and have fewer side effects from their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, ipilimumab, immunotherapy |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06438588 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a fasting mimicking diet (FMD) in reducing immune-related adverse events (irAEs) in cancer patients receiving immunotherapy. The FMD is a calorie-restricted, plant-based diet designed to mimic fasting while providing essential nutrients. Participants will receive nutrition counseling and follow a 4-day FMD regimen during three cycles of immunotherapy, with assessments of physical function, quality of life, and inflammation markers. The study aims to enhance patient well-being and minimize treatment side effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced stage malignancies receiving their first immunotherapy treatment.
Not a fit: Patients under 18, pregnant or nursing women, and those with certain health conditions or allergies to FMD components may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for cancer patients undergoing immunotherapy by reducing adverse side effects.
How similar studies have performed: While the concept of dietary interventions in cancer treatment is gaining interest, this specific approach using FMD in conjunction with immunotherapy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Age \< 18 years * Pregnant women * Nursing mothers * Persons of childbearing potential who are unwilling to employ adequate contraception * Patients will be excluded if they are on insulin due to diabetes \[diabetic patients will be asked to monitor their glucose levels with a continuous glucose monitoring (CGM) device\], if they have allergies to any of the components in the FMD, if there is unacceptable deterioration of their nutritional status and cancer progression
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Francis A. Farraye, MD, MS — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.