A Study to Evaluate the Effect of a Fasting Diet on Side Effects of Immunotherapy for Cancer Patients

Overview

About this study

The FMD-ICI study will utilize animal and human data that finds that fasting may promote survival mechanisms and stress resiliency. The study aims to assess the impact that a restrictive calorie diet, mostly of fat and complex carbohydrates, mimicking fasting and increasing resiliency will have in protecting patients from the adverse effects of certain cancer treatments (melanoma, lung, bladder and kidney cancer). By managing the adverse side effects of ICI treatments in select cancer patients, the study will assess the effect of immunotherapy plus the Xentigen fasting mimicking diet on adverse events rates, including immune-mediated colitis. Patients will be supplied with all their dietary requirements for 4 days, through a calorie-restrictive, Xentigen ‘Fasting Mimicking Diet'. The calorie-restrictive/fast-mimicking diet mimicks the effects of fasting on markers associated with stress resistance, reduction of glucose levels and increased levels of ketone bodies. We will also appraise the impact of immunotherapy plus the fasting mimicking diet on physical function nad quality of life as well as evaluate the impact of ummontherapy plus fasting mimicking diet on surrogate markers of inflammation (fecal calprotectin) as a predictive marker of immune-mediated colitis.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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:

  • Individuals < 18 years of age.
  • Pregnant women.
  • Nursing mothers.
  • Persons of childbearing potential who are unwilling to employ adequate contraception.

 

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Adam Perlman, M.D.

Closed-enrolling by invitation

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"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Heidi McLeod Ph.D.

(904) 953-2075

McLeod.Heidi@mayo.edu

More information

Publications

Publications are currently not available
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