A Study of 7-days Water-only Fasting in Patients With Metastatic Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
Activating the immune system to kill cancer cells is a promising therapeutic strategy for some patients with cancer. Unfortunately, current immune-targeting treatments do not work for patients with prostate cancer. In animal models of cancer, fasting can reprogram the body's metabolism and immune cell function to help immune cells kill cancer cells. The purpose of this study is to determine whether 7 days of water-only fasting or a very low-calorie diet is safe and feasible for patients with metastatic prostate cancer. This will help the investigators develop future studies to test whether incorporating periods of fasting or very low calorie diets into treatment plans for prostate cancer can improve outcomes from this disease.
Description
Seven days of water-only fasting is safe and feasible in healthy adults. Fasting enhances anti-tumor immunity in animal models of cancer. The primary objective of this study is to determine if 7 days of water-only fasting or a ketogenic very low-calorie diet is safe and feasible in patients with metastatic prostate cancer. Patients with metastatic prostate cancer will be instructed to perform a 7-day water-only fast followed by a 3-day refeeding protocol to evaluate safety and feasibility. Eligible patients are those with metastatic prostate adenocarcinoma. Patients will perform a 7-day water-…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 2. Age ≥18 years 3. Diagnosis of metastatic adenocarcinoma of the prostate 4. Must have a soft tissue metastasis amenable to biopsy 5. Prostate-specific antigen (PSA) is not currently declining, as determined by most recent 2 measurements taken at least 1 week apart in previous 2 months. 6. BMI between 20 and 35 kg/m2 7. Prior treatment with any prostate cancer therapy is permitted if \>2 weeks from last dose. Patients are not required to have received prior treatment for prostate cancer. 8. Prior treat…
Interventions
- BehavioralFasting
7 days of water-only fasting
Location
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland