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Brief Title: Fasting Mimicking Diet for Reducing Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors, FMD-ICI Trial

Effect of Fasting Mimicking Diet (FMD) on Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors: The FMD-ICI Feasibility Pilot Study


  • Org Study ID: 20-012936
  • Secondary ID: N/A
  • NCT ID: NCT06438588
  • Sponsor: Mayo Clinic


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.



I. Assess the impact of immunotherapy + FMD/Xentigen® on immune related adverse events rates (irAEs) (including immune-mediated colitis).

II. Appraise the impact of immunotherapy + FMD/Xentigen® on the patient's physical function and quality of life.

III. Evaluate the impact of immunotherapy + FMD/Xentigen® on surrogate markers of inflammation (i.e., fecal calprotectin) as a predictive marker of immune-mediated colitis.


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.

  • Overall Status
  • Start Date
    March 6, 2024
  • Phase
    Not Applicable
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


  • Lung Non-Small Cell Carcinoma
  • Lung Small Cell Carcinoma
  • Malignant Solid Neoplasm
  • Melanoma
  • Renal Cell Carcinoma
  • Urothelial Carcinoma


Inclusion Criteria:
* Age ≥ 18 years

- * Histological confirmation of melanoma, renal cell carcinoma, urothelial carcinoma, non-small cell lung carcinoma (squamous or adenocarcinoma), and small cell lung carcinoma

- * Advanced stage disease (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 diabetic, if they have allergies to any of the components in the FMD, if there is unacceptable deterioration of their nutritional status and cancer progression

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: Francis A. Farraye, MD, MS

Role: Principal Investigator

Affiliation: Mayo Clinic

Overall Contact

Name: N/A

Phone: N/A

Email: N/A


Facility Status Contact
Facility: Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
United States
Status: Recruiting Contact: Contact
Clinical Trials Referral Office

Principal Investigator
Francis A. Farraye, MD, MS