Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Dietary Intervention | Other | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Nutritional Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (FMD)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Dietary Intervention
- Other: Educational Intervention
- Other: Electronic Health Record Review
- Other: Interview
- Other: Nutritional Assessment
- Other: Questionnaire Administration
Primary outcomes (5)
- measure
- Symptom Measurement
- timeFrame
- Up to 6 months
- description
- Symptoms will be measured using a modified version of the Memorial Symptom Assessment Scale. The modified version will contain specific items related to side effects of immune checkpoint inhibitors (ICIs) including twelve GI symptoms, skin changes, and fatigue. The scale includes 24 items for which the participant reports on whether a symptom (e.g., pain, lack of energy, shortness of breath) occurred during the previous week, as well as any distress it may have caused. Questions are answered on a 0-4 or 0-4 scale (e.g., 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost Constantly).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available