Trial Title:
Fasting Mimicking Diet for Reducing Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors, FMD-ICI Trial
NCT ID:
NCT06438588
Condition:
Lung Non-Small Cell Carcinoma
Malignant Solid Neoplasm
Melanoma
Renal Cell Carcinoma
Urothelial Carcinoma
Endometrial Carcinoma (EC)
Malignant Uterine Neoplasm
Conditions: Official terms:
Carcinoma
Neoplasms
Carcinoma, Renal Cell
Endometrial Neoplasms
Carcinoma, Non-Small-Cell Lung
Uterine Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Supportive Care (FMD)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Dietary Intervention
Description:
Given FMD
Arm group label:
Supportive Care (FMD)
Other name:
Dietary Modification
Other name:
intervention, dietary
Other name:
Nutrition Intervention
Other name:
Nutrition Interventions
Other name:
Nutritional Interventions
Intervention type:
Other
Intervention name:
Educational Intervention
Description:
Receive educational guidelines
Arm group label:
Supportive Care (FMD)
Other name:
Education for Intervention
Other name:
Intervention by Education
Other name:
Intervention through Education
Other name:
Intervention, Educational
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Supportive Care (FMD)
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Supportive Care (FMD)
Intervention type:
Other
Intervention name:
Nutritional Assessment
Description:
Receive nutrition counseling
Arm group label:
Supportive Care (FMD)
Other name:
Dietary Assessment
Other name:
dietary counseling
Other name:
nutritional counseling
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Supportive Care (FMD)
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 years
- Histological confirmation of melanoma, renal cell carcinoma, urothelial carcinoma,
non-small cell lung carcinoma (squamous or adenocarcinoma), endometrial, and uterine
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
Locations:
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Francis A. Farraye, MD, MS
Start date:
March 6, 2024
Completion date:
March 15, 2027
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06438588
https://www.mayo.edu/research/clinical-trials
