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Fasting Mimicking Diet for Cancer

N/A
Recruiting
Led By Francis A. Farraye, MD, MS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
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
Must not have
Age < 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find a way to help cancer patients manage the side effects of their treatment by following a specific diet called the fast mimicking diet (FMD). The FMD is a plant-based

Who is the study for?
This trial is for cancer patients undergoing immunotherapy who may experience side effects like skin rash, diarrhea, and fatigue. It's suitable for those with specific cancers such as renal cell carcinoma and melanoma. Participants should be willing to follow a special diet mimicking fasting.
What is being tested?
The study tests if a fasting mimicking diet (FMD) can reduce immune-related side effects in cancer patients on immune checkpoint inhibitors. The FMD includes plant-based foods designed to lessen the burden of fasting while providing essential nutrients.
What are the potential side effects?
Potential side effects from the FMD could include hunger, weakness, headaches or irritability due to calorie restriction. However, it aims to minimize adverse reactions typically associated with complete fasting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My advanced cancer is suitable for specific immune treatments.
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My cancer is confirmed as melanoma, kidney, bladder, or lung cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fecal calprotectin
Incidence of adverse events
Physical function
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive Care (FMD)Experimental Treatment7 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,319 Previous Clinical Trials
3,068,802 Total Patients Enrolled
42 Trials studying Melanoma
2,530 Patients Enrolled for Melanoma
Francis A. Farraye, MD, MSPrincipal InvestigatorMayo Clinic
~7 spots leftby Mar 2027
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