Status:
COMPLETED
Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Localized Prostate Carcinoma
Prostate Adenocarcinoma
Eligibility:
MALE
40+ years
Phase:
NA
Brief Summary
This clinical trial studies the effects of a diet and physical activity intervention on blood measures of lipids and insulin resistance in patients with prostate cancer undergoing radiation therapy (R...
Detailed Description
OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (DIET AND PHYSICAL ACTIVITY): Patients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instruc...
Eligibility Criteria
Inclusion
- Age \>= 40 years
- Histologically confirmed adenocarcinoma of the prostate, (D'Amico risk category intermediate or high risk, localized or locoregional)
- Primary treatment is RT + ADT \[Zoladex, Lupron, Degarelix, and other luteinizing hormone-releasing hormone (luteinizing hormone releasing hormone \[LHRH\])-directed therapies\] with standard RT dose and fractionation (anti-androgen monotherapy will not be allowed
- Physically able to undertake an exercise program
Exclusion
- Advanced, metastatic disease
- Planning to join a commercial/structured diet change or fitness program
- Have significant pre-existing T2D (poor glycemic control while on medication, defined as hemoglobin A1c of \>= 10 within the prior 12 months) or significant pre-existing cardiovascular disease (CVD) (myocardial infarction or stroke within prior six months)
- Physician confirmed cognitive impairment or alcohol/narcotic abuse
Key Trial Info
Start Date :
November 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04870515
Start Date
November 4 2021
End Date
December 18 2024
Last Update
January 9 2026
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109