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

Melanoma Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438588
• Other study ID #: 20-012936
• Secondary ID: NCI-2024-0351520
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2024
• Est. completion date: March 15, 2027

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 15, 2027
• Est. primary completion date: March 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Biospecimen Collection
Undergo blood sample collection

Other:
• Dietary Intervention
Given FMD
• Educational Intervention
Receive educational guidelines
• Electronic Health Record Review
Ancillary studies
• Interview
Ancillary studies
• Nutritional Assessment
Receive nutrition counseling
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Measurement	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).	Up to 6 months
Primary	Incidence of adverse events	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.	Up to 6 months
Primary	Physical function	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.	Up to 6 months
Primary	Quality of life - FACT-G	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.	Up to 6 months
Primary	Fecal calprotectin	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.	At baseline, week 12 and week 24

External Links

•   Mayo Clinic Clinical Trials