Actively Recruiting
A Study of 7-days Water-only Fasting in Patients With Metastatic Prostate Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-07-08
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
A
Abott Lingo Wearables
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether 7 days of water-only fasting or a very low-calorie ketogenic diet is safe and doable for men with metastatic prostate cancer. Current immune-targeting treatments have limited success for this cancer, and animal studies suggest fasting may help the immune system better target cancer cells. This study aims to gather information to guide future research on integrating fasting or diet approaches into prostate cancer treatment plans. Participants will undergo a 7-day water-only fast, followed by a 3-day period of refeeding. If needed, they can switch to a ketogenic very low-calorie diet during the fasting period. The study focuses on safety and feasibility for men with metastatic prostate adenocarcinoma, with careful monitoring through regular laboratory tests and a clinic visit on Day 3. Throughout the study, participants will have their health and quality of life assessed using surveys and step counts from Day 1 to Day 10. Adverse events will be recorded over one year to evaluate safety. The study lasts about 10 days of active participation, with follow-up to track how many complete the fasting or diet and any related side effects.
CONDITIONS
Brief Title
7-Days Water-Only Fasting Trial in Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Age 18 years or older
- Diagnosis of metastatic adenocarcinoma of the prostate
- Presence of a soft tissue metastasis that can be biopsied
- Stable or non-declining prostate-specific antigen (PSA) levels based on recent tests
- Body mass index (BMI) between 20 and 35 kg/m2
- Prior prostate cancer treatment allowed if more than 2 weeks since last dose
- Prior steroid treatment allowed if more than 2 weeks since last dose and able to stop steroids
- Liver function within acceptable limits (bilirubin less than 2.5 times normal, AST and ALT less than 2.5 times normal)
- Kidney function with glomerular filtration rate (GFR) of 50 mL/min/1.73 m2 or higher
- Adequate blood counts (neutrophils, platelets, hemoglobin) within specified ranges
- Electrolyte and acid/base levels within specified acceptable ranges
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher
- Unintentional weight loss of 5% or more in the past 3 months
- Diabetes mellitus (HbA1c 6.5% or higher or use of diabetes medications)
- Active uncontrolled infection
- Use of immunosuppressive medications including steroids
- Use of diuretics or beta blockers
- History of heart rhythm problems, heart attack, valve disease, or high blood pressure in the lungs
- Abnormal screening electrocardiogram (EKG)
- Daily alcohol consumption
- Any condition or mental impairment that affects ability to consent, safety, or study compliance as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants perform a 7-day water-only fast followed by a 3-day refeeding protocol to evaluate safety and feasibility. Participants may switch to a ketogenic very low-calorie diet anytime between Day 1 and Day 7.
1 clinic visit on Day 3 with regular lab monitoring
Trial Site Locations
Total: 1 location
1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Actively Recruiting
Research Team
L
Laura Sena, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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