A Study of 7-days Water-only Fasting or Ketone Supplementation in Patients With 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 likely by increasing ketosis. The purpose of this study is to determine whether 7 days of water-only fasting or a ketogenic very low-calorie diet or ketone supplementation is safe and feasible for patients with prostate cancer. This will help the investigators develop future studies to test whether incorporating periods of fasting or very low calorie diets or a ketone supplement 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 likely through ketosis. The primary objective of this study is to determine if 7 days of water-only fasting or a ketogenic very low-calorie diet or ketone supplementation is safe and feasible in patients with prostate cancer. Patients with 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. Two cohorts will be evaluated including (1) patients with local prostate canc…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Age ≥18 years * Diagnosis of adenocarcinoma of the prostate * If a soft tissue metastasis amenable to biopsy is present, then the participant must agree to biopsies. * If the participant has local prostate cancer, then the participant must agree to prostate biopsy or radical prostatectomy on days 8, 9, or 10. -. 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. * BMI between 20 and 35 kg/m2 * Prior t…
Interventions
- BehavioralFasting
7 days of water-only fasting
- Dietary SupplementKetone Supplementation
7 days of ketone supplementation
Location
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland