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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05054296.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Christopher J. Logothetis
Phone: 713-563-7210
League City
MD Anderson League CityStatus: Active
Contact: Christopher J. Logothetis
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. Screen for a relationship between a 16-week exercise program with continuous Fitbit monitoring and metabolic syndrome severity (defined by change in metabolic severity index z-score), as compared to Fitbit monitoring alone, in prostate cancer patients on ADT.
III. Measure the relationship between the exercise intervention and prostate-specific antigen (PSA) velocity, compared to Fitbit monitoring alone.
IV. Measure the relationship between the exercise intervention and physical fitness (using V02 and body composition), compared to Fitbit monitoring alone.
V. Measure the relationship between the exercise intervention and physical activity (step count)/heart rate, compared to Fitbit monitoring alone.
VI. Measure the relationship between the exercise intervention and physical activity (as measured by the Godin Leisure Time Physical Activity Questionnaire) compared to Fitbit monitoring alone.
VII. Measure the relationship between the exercise intervention and, quality of life/symptom burden, compared to Fitbit monitoring alone (measured by the following patient reported surveys: National Cancer Institute-patient reported outcomes-Common Terminology Criteria for Adverse Events [NCI-PRO-CTCAE], Patient Reported Outcomes Measurement Information System [PROMIS] Fatigue and Physical Function, Self Efficacy, European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Core30 [QLQ-C30] and Prostate Cancer 25 [PR25]).
EXPLORATORY OBJECTIVE:
I. Explore the relationship between the exercise intervention and markers of insulin resistance, inflammation/immune function and metabolism utilizing pre- and post-intervention peripheral blood analysis.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive general education exercise packet with instruction to exercise regularly for up to 150 minutes weekly. Patients also wear a FitBit daily over 16 weeks.
GROUP II: Patients participate in supervised and self-directed exercise sessions over 60 minutes twice a week (BIW) for up to 16 weeks. Patients also wear a FitBit daily over 16 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorChristopher J. Logothetis
