7-Days Water-Only Fasting or Ketone Supplementation Trial in Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
ECOG Performance status ≥2
Unintentional weight loss greater than or equal to 5% in previous 3 months
Diabetes mellitus, defined as HbA1c ≥6.5% or use of medications for diabetes
Active uncontrolled infection. Patients with a history of HIV/AIDS may be eligible if CD4+ T cell counts are ≥ 350 cell/ul, the patients have had no opportunistic infection within the past 12 months, they have been on established antiretroviral therapy (ART) for at least four weeks, and the HIV viral load is less than 400 copies/ml prior to enrollment. Patients with a history of hepatitis C virus (HCV) infection are eligible if the patients have completed curative antiviral treatment and the HCV viral load is below the limit of quantification.
Trial design
Design model
Parallel
Treatments tested in this trial
Fasting
Behavioral7 days of water-only fasting
Ketone Supplementation
Dietary supplement7 days of ketone supplementation
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Fasting with Local Prostate CancerExperimental treatment 1 intervention
Group B: Ketone Supplementation with Local Prostate CancerExperimental treatment 1 intervention
Group C: Fasting with Metastatic Prostate CancerExperimental treatment 1 intervention
Group D: Ketone Supplementation with Metastatic Prostate CancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of adverse events and serious adverse events (SAEs)
Number of adverse events and serious adverse events (SAEs) assessed according to CTCAE v5.0
Time frame
1 year2
Number patients who complete 7 days of fasting or the ketogenic very low-calorie diet of ketone supplementation of all enrolled patients.
Number patients who complete 7 days of fasting or the ketogenic very low-calorie diet of ketone supplementation of all enrolled patients.
Time frame
1 yearSecondary outcomes
1
Changes in quality of life and function using Functional Assessment of Cancer Therapy - General (FACT-G) survey
Changes in quality of life and function during the study by: Score of a daily modified FACT-G survey. Score range 0-108, higher score better quality of life.
Time frame
Screening and daily from Day 1 to Day 102
Changes in quality of life and function based on number of steps
Changes in quality of life and function during the study based on the number of steps per day by an activity tracker.
Time frame
Daily from Day 1 to Day 10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Abott Lingo Wearables
Collaborator
United States Department of Defense
Collaborator
Prostate Cancer Foundation
Collaborator
Source ClinicalTrials.gov