Fasting Mimicking Diet for Reducing Immune Related Adverse Events for Cancer Patients on I
This clinical trial assesses an effective and translatable care model to understand and reduce the adverse effects that cancer patients experience during their treatment therapies and thereby enhance their well-being and quality of life. Excessive immune activation can affect multiple organs with the most common advers
| Condition(s) | Advanced Malignant Solid Neoplasm |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This clinical trial assesses an effective and translatable care model to understand and reduce the adverse effects that cancer patients experience during their treatment therapies and thereby enhance their well-being and quality of life. Excessive immune activation can affect multiple organs with the most common adverse effects being skin rash, diarrhea, colitis, fatigue, hypothyroidism and anorexia. A restrictive calorie diet, mostly of fat and complex carbohydrates, will mimic fasting and increase resiliency to protect patients from the adverse effects of cancer treatments, by managing the adverse side effects of immune checkpoint inhibitors (ICI) treatments in select cancer patients. The fast mimicking diet (FMD) (Xentigen®) is a calorie restrictive, low-calorie, low-protein, high compl |
| Who can participate | Inclusion Criteria: * Patients undergoing immunotherapy regardless of prior immunotherapy history * Age ≥ 18 years * Body mass index (BMI) \> 19 * Histological confirmation of advanced staged 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Mayo Clinic |
| Locations | Jacksonville, Florida, United States |
| Start date | 2024-03-06 |
| NCT ID | NCT06438588 |
| Official listing | https://clinicaltrials.gov/study/NCT06438588 |