Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05054296
Phase
PHASE2
Status
Recruiting
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Conditions

  • Biochemically Recurrent Prostate Carcinoma
  • Metastatic Prostate Adenocarcinoma
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Educational Intervention — BEHAVIORAL
    Receive general education exercise packet
  • Exercise Intervention — BEHAVIORAL
    Participate in supervised and self-directed exercise sessions
  • FitBit — DEVICE
    Wear FitBit for activity tracking
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

First listed
Sep 23, 2021
Start date
Mar 23, 2020
Status verified
Mar 2023
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Group I (education exercise packet, FitBit)
    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.
  • Experimental: Group II (exercise program FitBit)
    Patients participate in supervised and self-directed exercise sessions over 60 minutes BIW for up to 16 weeks. Patients also wear a FitBit daily over 16 weeks.

Primary Outcome Measure

Atherosclerotic cardiovascular disease (ASCVD) 10-year risk score [ Time Frame: Through the study completion, an average of a year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Christopher J. Logothetis
713-792-2830
Christopher J. Logothetis (PRINCIPAL_INVESTIGATOR)

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M D Anderson Cancer Center· Houston, TX

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