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

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

Overview

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 + 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.

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.

Interventions

• Procedure Biospecimen Collection
  Undergo blood sample collection
• Other Dietary Intervention
  Given FMD
• Other Educational Intervention
  Receive educational guidelines
• Other Electronic Health Record Review
  Ancillary studies
• Other Interview
  Ancillary studies
• Other Nutritional Assessment
  Receive nutrition counseling
• Other Questionnaire Administration
  Ancillary studies

Primary outcome measures

• Symptom Measurement [Time frame: Up to 6 months]
• Incidence of adverse events [Time frame: Up to 6 months]
• Physical function [Time frame: Up to 6 months]
• Quality of life - FACT-G [Time frame: Up to 6 months]
• Fecal calprotectin [Time frame: At baseline, week 12 and week 24]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT06438588 · 20-012936

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗