This phase II trial is to determine whether exercise improves cardiovascular risk factors in Black men with prostate cancer that has not spread to other parts of the body (localized) or has spread to other places in the body (metastatic) receiving androgen deprivation therapy (ADT). A structured exercise program may improve body composition, physical fitness and function, quality of life, and reduce the risk of cardiovascular disease and cancer symptoms.
Additional locations may be listed on ClinicalTrials.gov for NCT05327465.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Christina Dieli-Conwright
Phone: 617-582-8321
Beth Israel Deaconess Medical CenterStatus: Approved
Contact: David Einstein
PRIMARY OBJECTIVE:
I. To examine the effects of the exercise intervention on cardiovascular disease (CVD) risk factors assessed by the Framingham Risk Score, an established comprehensive tool for evaluating the risk of developing CVD using blood samples, demographic and medical profiles, and lifestyle behaviors.
SECONDARY OBJECTIVE:
I. To examine the effects of exercise on objectively measured cardiorespiratory capacity (i.e., peak oxygen consumption), muscular strength (i.e., 1-repetition maximum), and body composition (i.e., lean body mass and body fat mass).
TERTIARY OBJECTIVE:
I. To examine the effects of exercise on quality of life, treatment-related symptoms, and psychosocial outcomes.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (EXERCISE): Participants undergo the structured exercise intervention consisting of a home-based, virtually supervised progressive aerobic and resistance program over 60-70 minutes 3 times a week for 16 weeks (on weeks 2-17). Participants also undergo a physical activity level test and blood sample collection throughout the study.
GROUP II: Participants receive usual care for 16 weeks. Participants may then undergo structured exercise intervention as in group I. Participants also undergo a physical activity level test and blood sample collection throughout the study.
After completion of study intervention, patients are followed up at week 52.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorChristina Dieli-Conwright