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NCT Number: NCT06438588

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

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.

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Key information

Conditions

Advanced Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Francis A. Farraye, MD, MS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Dietary Intervention

Other

Given FMD

Other names: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Educational Intervention

Other

Receive educational guidelines

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Electronic Health Record Review

Other

Ancillary studies

interview

Other

Ancillary studies

Nutritional Assessment

Other

Receive nutrition counseling

Other names: Dietary Assessment, dietary counseling, nutritional counseling

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Symptom Measurement

    Time frame: Up to 6 months

    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).

  2. Incidence of adverse events

    Time frame: Up to 6 months

    Will grade the severity of symptoms using the CTCAE v3.0 scale. Will report descriptive analysis of rates and means. Patients will also be asked to report on any incidences of involuntary fasting due to their symptoms.

  3. Physical function

    Time frame: Up to 6 months

    Physical function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function, a 10-item measure of mobility and extremity function that was specifically developed for use in cancer, populations. Items are scored from 1-5 each with higher scores indicating better physical function.

  4. Quality of life - FACT-G

    Time frame: Up to 6 months

    Quality of life will be measured using the seven item Functional Assessment of Cancer Therapy (FACT-G), an abbreviated version of the FACT-G. Each item is scored from 0 (not at all) to 4 (very much). Higher overall scores correspond with better quality of life.

  5. Fecal calprotectin

    Time frame: At baseline, week 12 and week 24

    Fecal calprotectin will be measured by patients who develop diarrhea or the gastrointestinal side effects. Will be obtained as standard of care to assess for immune mediated colitis if CTCAE v3.0 score is greater than 1.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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