Back to Search Results- Active Not Recruiting
- Prevention
- Interventional
- Randomized
- Behavioral & Other
- Roswell Park Cancer Institute
- 18 Years -
Study Purpose
This clinical trial examines weight loss interventions in reducing cancer progression in prostate cancer patients under active surveillance. Intensive lifestyle interventions that recommend modest reductions in daily caloric intake (i.e. continuous calorie energy reduction \[CER\]) are the gold-standard for weight loss, and have been tested in cancer survivors, including prostate cancer patients. However, few interventions have been developed for low-risk prostate cancer patients on active surveillance. Intermittent fasting (IF) may be superior to CER in the context of prostate cancer progression given its dual role in weight loss and metabolic switching from the use of glucose as a fuel source to the use of fatty acids and ketone bodies. This study may help researchers determine which weight loss strategies can reduce their risk of prostate cancer recurrence, and other negative health effects of being overweight or obese.
Intervention
Procedure : Biospecimen Collection
Other : Dietary Intervention
Other : Dietary Intervention
Behavioral : Fasting
Eligibility Requirements
Age 18 years old or older (no upper limit)
Body mass index (BMI) \>= 25 kg/m\^2
English speaking
Not currently on weight loss medications
Prostate cancer patients who are under active surveillance (including observation) and actively followed at Roswell Park
Not under active treatment for other cancer diagnosis
Free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
Has not lost at least 10% of their body weight in the last 6 months
Has not had bariatric surgery in the last 10 years
Able to walk unassisted and continuously for 10 minutes
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Unable to consent
Unwilling or unable to follow protocol requirements
Unable to complete study measures in English
Adults who have had a myocardial infarction (heart attack) or stroke without medical clearance from their primary care physician to participate in the study
Adults who currently have type 1 or type 2 diabetes without medical clearance from their primary care physician to participate in the study
History of partial or radical prostatectomy
Recruiting status
Active Not Recruiting
Estimated enrollment
20
Study start date
Apr 24, 2024
Study end date
Apr 30, 2025
Last updated
Mar 22, 2025
Primary purpose
Prevention
Design
Interventional
Intervention
Behavioral & Other
Study phase
NA
Allocation
Randomized
Sponsor:
Roswell Park Cancer Institute
Collaborator:
N/A
Investigator:
Karen Yeary
N/A
Publications
N/A
Websites
N/A
NCT05764330
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