Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Supervised Exercise Program and Continuous Fitbit Monitoring
M.D. Anderson Cancer Center
Summary
This phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response to treatment (refractory) and are receiving androgen deprivation therapy. Balancing treatment efficacy, drug side effects, and competing comorbidities with prostate cancer is essential. This trial is being done to learn if an exercise program can help to improve metabolic syndrome and cardiovascular (heart) fitness in prostate cancer patients who are receiving androgen deprivation therapy.
Description
PRIMARY OBJECTIVE: I. Determine the relationship between a 16-week exercise program with continuous Fitbit monitoring and cardiovascular fitness (defined by change in 10-year atherosclerotic cardiovascular disease \[ASCVD\] risk score), as compared to Fitbit monitoring alone, in prostate cancer patients on androgen deprivation therapy (ADT). SECONDARY OBJECTIVES: I. Determine the length of cardiovascular fitness effect (measured using 10-year ASCVD risk 12 weeks post intervention) for a 16-week exercise program with continuous Fitbit monitoring in prostate cancer patients on ADT. II. Scree…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Willing and able to provide written informed consent * Histologically or cytologically confirmed adenocarcinoma of the prostate * Presence of metastatic disease documented on imaging studies (bone scan, computed tomography \[CT\] and/or magnetic resonance imaging \[MRI\]) or biochemical recurrence/refractoriness following local therapy (prostatectomy or radiation) * Stable or improving disease activity as demonstrated by stable or improving PSA over at least 2 months * On gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or status post-surgical castration…
Interventions
- BehavioralEducational Intervention
Receive general education exercise packet
- BehavioralExercise Intervention
Participate in supervised and self-directed exercise sessions
- DeviceFitBit
Wear FitBit for activity tracking
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Location
- M D Anderson Cancer CenterHouston, Texas