7-Days Water-Only Fasting or Ketone Supplementation Trial in Prostate Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT06826924
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fasting — BEHAVIORAL
    7 days of water-only fasting
  • Ketone Supplementation — DIETARY_SUPPLEMENT
    7 days of ketone supplementation

Study Details

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.

Key Dates

First listed
Feb 14, 2025
Start date
Jun 3, 2025
Status verified
Jun 2026
Primary completion
Jun 3, 2027
Completion
Jun 3, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fasting with Local Prostate Cancer
    7-day water-only fast followed by a 3-day refeeding
  • Experimental: Ketone Supplementation with Local Prostate Cancer
    7-day ketone supplementation
  • Experimental: Fasting with Metastatic Prostate Cancer
    7-day water-only fast followed by a 3-day refeeding
  • Experimental: Ketone Supplementation with Metastatic Prostate Cancer
    7-day ketone supplementation

Primary Outcome Measure

Number of adverse events and serious adverse events (SAEs) [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231

Find similar trials in Baltimore, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD

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