Actively Recruiting
7-Days Water-Only Fasting Trial in Prostate Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-07-08
10
Participants Needed
1
Research Sites
52 weeks
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
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.
CONDITIONS
Official 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
- Must have a soft tissue metastasis suitable for biopsy
- Prostate-specific antigen (PSA) not currently declining 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 be weaned off steroids
- Liver function with bilirubin less than 2.5 times upper limit of normal (ULN)
- Liver enzymes AST and ALT less than 2.5 times ULN
- Kidney function with glomerular filtration rate (GFR) of 50 mL/min/1.73 m2 or higher
- Blood counts with ANC ≥1500 cells/mm3, platelets ≥100,000/mm3, and hemoglobin ≥8 g/dL
- Electrolyte and acid/base levels within specified normal ranges
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- ECOG Performance Status 2 or higher
- Unintentional weight loss of 5% or more in past 3 months
- Diabetes mellitus with HbA1c ≥6.5% or using diabetes medications
- Active uncontrolled infection
- Use of immunosuppressive medications including steroids
- Use of diuretics or beta blockers
- History of cardiac arrhythmia, heart attack, valvular heart disease, or pulmonary hypertension
- Abnormal screening EKG
- Daily alcohol use
- Any condition or mental impairment that affects ability to consent, safety, or study compliance as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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