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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the study completion, an average of a year.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Atherosclerotic cardiovascular disease (ASCVD) 10-year risk score
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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,146 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,654 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 Patients Enrolled for Prostate Cancer
Christopher J LogothetisPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have bone pain due to cancer spread.My platelet count is at least 75,000 without transfusions in the last 3 months.I haven't had chemotherapy in the last 28 days.I do not have serious heart conditions that would make exercise unsafe.My cancer has spread, as shown by scans, or it came back after surgery or radiation.My PSA levels have been stable or improving for at least 2 months.I do not have any active cancer other than prostate cancer.You are currently required to stay in a hospital for treatment of a mental or physical illness.I am currently on hormone therapy with abiraterone or enzalutamide.I have untreated spinal cord issues causing symptoms.I am only using specific treatments for my prostate cancer, not any other systemic therapy.I can complete a strenuous exercise test under a doctor's supervision.I haven't been able to walk 400 meters or do arm and leg exercises in the last 3 months.My hemoglobin level is 9.0 g/dL or higher without transfusions in the last 3 months.I have bone metastasis but no symptoms.I expect to have low testosterone levels for at least the next 6 months.I can take care of myself and am up and about more than half of my waking hours.You are not taking any experimental drugs.I have been on hormone therapy or had surgical castration for over 3 months.I have had radiation or surgery for bone metastasis before.Your heart's electrical activity is too slow, shown on a test called electrocardiogram (ECG).My prostate cancer was confirmed by a lab test.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (education exercise packet, FitBit)
- Group 2: Group II (exercise program FitBit)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is enrollment for this research endeavor being conducted?
"Affirmative. Clinicaltrials.gov affirms that this experiment is actively recruiting participants, which was first announced on March 23rd 2020 and most recently updated September 27th 2022. 200 candidates are needed from 1 site for the trial to be considered successful."
Answered by AI
Has Exercise Intervention been granted regulatory approval by the FDA?
"Based on the data available, our team at Power has assigned exercise intervention a score of 2 due to its Phase 2 trial status; there is evidence for safety but not yet efficacy."
Answered by AI
Is there availability for participants in this medical experiment?
"Affirmative. According to the clinicaltrials.gov portal, this medical study is currently enrolling patients with a posted start date of March 23rd 2020 and last update on September 27th 2022. The research aims to recruit two hundred participants from just one trial site."
Answered by AI
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