RecruitingPhase 2NCT05054296

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

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

200 participants

Start Date

Mar 23, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a structured risk-reduction program (diet, exercise, and cardiovascular monitoring using a Fitbit) can help reduce heart disease risk and metabolic problems in men with prostate cancer who are taking hormone-blocking therapy (ADT — androgen deprivation therapy). ADT is an effective cancer treatment but often causes weight gain, diabetes risk, and heart issues. **You may be eligible if...** - You are a man with confirmed prostate cancer that has spread or has come back after local treatment - You have been on hormone-blocking therapy (GnRH agonist, antagonist, or surgical castration) for at least 3 months - Your cancer is stable or improving on treatment - You are expected to remain on hormone therapy for at least 6 more months - You are willing to wear a Fitbit and participate in the program **You may NOT be eligible if...** - You have uncontrolled diabetes, severe heart disease, or other major conditions that make exercise unsafe - You are unable to participate in a physical activity program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05054296


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