This clinical trial evaluates whether dietary intervention and exercise works for improving weight loss and lowering cardiovascular (heart) disease risk factors (CVRFs) in men with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and are undergoing androgen deprivation therapy (ADT). ADT is a widely used treatment for men with prostate cancer disease to lower the male hormone, androgen, to stop it from causing prostate cancer cell growth. A majority of men on ADT gain weight contributing to an increase in CVRFs and cardiovascular morbidity (disease). Dietary intervention combined with exercise have shown success in reducing weight/fat mass and improving CVRFs. Dietary intervention and exercise may improve weight loss and lower risk factors for heart disease in men with metastatic prostate cancer undergoing ADT.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06682390.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer CenterStatus: Active
Contact: Zhaoping Li
Phone: 310-206-1987
PRIMARY OBJECTIVE:
I. Compare effect of a hypocaloric, anti-inflammatory diet on changes in fat mass between African- American versus (vs) non-Hispanic white men with metastatic prostate cancer on ADT therapy.
SECONDARY OBJECTIVE:
I. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cardiovascular risk factors (body weight, lean body mass, waist-to-height ratio, blood pressure, lipids and hemoglobin [Hb]A1c) and inflammatory markers (high-sensitivity C-reactive protein [hs-CRP] and cytokines) between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.
TERTIARY OBJECTIVE:
I. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cancer-related fatigue and quality of life between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.
OUTLINE:
PHASE 1: Patients consume usual diet and perform their usual physical activity for 3 months.
PHASE 2: Patients consume a hypocaloric (approximately 500 kcal daily reduction), anti- inflammatory diet and walk for 1 hour three times per week (TIW) for 3 months. Patients also meet with a Registered Dietitian via phone or video at the beginning of Phase 2 and then every 2 weeks thereafter for 3 months.
Patients also undergo blood sample collection on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorZhaoping Li
