Fasting Mimicking Diet for Reducing Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors, FMD-ICI Trial

Launched by MAYO CLINIC · May 31, 2024

Keywords

ClinConnect Summary

The FMD-ICI trial is studying a special diet called the Fasting Mimicking Diet (FMD) to see if it can help reduce the uncomfortable side effects that some cancer patients experience while undergoing treatments with immune checkpoint inhibitors. These treatments are used for advanced stages of certain cancers, including melanoma and lung cancer, and can sometimes lead to issues like skin rashes, diarrhea, fatigue, and other symptoms. The FMD is a plant-based, low-calorie diet that provides essential nutrients while mimicking the effects of fasting, which may help improve patients' resilience and overall well-being during their cancer treatment.

To participate in this trial, individuals need to be at least 18 years old and have a confirmed diagnosis of specific advanced cancers that are being treated with certain immunotherapy drugs. Participants will follow the FMD, which includes foods like vegetable soups, energy bars, and herbal teas, all designed to be safe and nutritious. It's important to note that this trial is not open to pregnant or nursing women or those with certain medical conditions, such as diabetes or severe allergies related to the diet components. Overall, the study aims to enhance the quality of life for cancer patients while they receive their treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients undergoing immunotherapy for their first time
• • Age ≥ 18 years
• • Body mass index (BMI) \> 19
• • Histological confirmation of advanced stage malignancies (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 they are on insulin due to diabetes (diabetic patients will be asked to monitor their glucose levels with a continuous glucose monitoring \[CGM\] device), if they have allergies to any of the components in the FMD, if there is unacceptable deterioration of their nutritional status and cancer progression

Trial Officials