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Exercise Program + Fitbit Monitoring for Prostate Cancer

Phase 2

Recruiting

Led By Christopher J Logothetis

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be able to finish a maximal exercise stress test which will be assessed by cardiopulmonary exercise testing using a standardized protocol supervised by a cardiologist

Platelet count >=75,000/uL independent of transfusion and/or growth factors within 3 months prior to enrollment

Must not have

Clinically significant heart disease that may impact safety of independent or supervised exercise including preexisting coronary artery disease, myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes), New York Heart Association Class III-IV heart disease or cardiac ejection fraction measurement of < 40% at baseline

Symptomatic bone metastasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the study completion, an average of a year.

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well an exercise program and Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in prostate cancer patients receiving androgen deprivation therapy.

Who is the study for?

This trial is for men with metastatic or recurrent prostate cancer that's resistant to treatment and are on hormone therapy. They should be able to perform physical activities, have stable disease, and not be undergoing certain other treatments. Participants need a smartphone and must speak English.

What is being tested?

The study tests if an exercise program along with continuous Fitbit monitoring can manage metabolic syndrome and reduce heart disease risk in prostate cancer patients on hormone therapy. It includes quality-of-life assessments, questionnaires, and educational components.

What are the potential side effects?

While the intervention mainly involves exercise which is generally safe, potential side effects may include typical risks associated with physical activity such as muscle strains or injuries especially if participants have bone metastasis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can complete a strenuous exercise test under a doctor's supervision.

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My platelet count is at least 75,000 without transfusions in the last 3 months.

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My cancer has spread, as shown by scans, or it came back after surgery or radiation.

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My hemoglobin level is 9.0 g/dL or higher without transfusions in the last 3 months.

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I expect to have low testosterone levels for at least the next 6 months.

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I can take care of myself and am up and about more than half of my waking hours.

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My prostate cancer was confirmed by a lab test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart conditions that would make exercise unsafe.

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I have bone pain due to cancer spread.

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I do not have any active cancer other than prostate cancer.

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I have untreated spinal cord issues causing symptoms.

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I haven't been able to walk 400 meters or do arm and leg exercises in the last 3 months.

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I have had radiation or surgery for bone metastasis before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the study completion, an average of a year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the study completion, an average of a year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the study completion, an average of a year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Atherosclerotic cardiovascular disease (ASCVD) 10-year risk score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group II (exercise program FitBit)Experimental Treatment4 Interventions

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.

Group II: Group I (education exercise packet, FitBit)Active Control4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Intervention

2016

Completed Phase 4

~1330

FitBit

2017

N/A

~480