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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

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

0 / 4Eligibility criteria met