A Study to Evaluate the Effect of a Fasting Diet on Side Effects of Immunotherapy for Cancer Patients
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Jacksonville, Florida: 20-012936
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.
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.
- 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.
- 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
Mayo Clinic principal investigator
Adam Perlman, M.D.
Closed-enrolling by invitation
Heidi McLeod Ph.D.
Publications are currently not available