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NCT05054296 · ClinicalTrials.gov registry record · Phase 2
Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring
A Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Stage IV Prostate Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT05054296 is a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Stage IV Prostate Cancer AJCC v8 that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 200 participants, above the 173-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (16% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05054296, a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Stage IV Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- BEHAVIORAL Educational Intervention
- BEHAVIORAL Exercise Intervention
- DEVICE FitBit
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2020-03-23 |
| Est. Completion | 2027-02-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05054296
The ClinicalTrials.gov registry entry for NCT05054296 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 173-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (16% higher). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT05054296 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05054296 about?
NCT05054296 is a clinical study titled "Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring". 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 ...
What is the current status of trial NCT05054296?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2020-03-23. Estimated completion is 2027-02-02.
What conditions does trial NCT05054296 study?
This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Metastatic Prostate Adenocarcinoma, Biochemically Recurrent Prostate Carcinoma.
What interventions are being tested in trial NCT05054296?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Educational Intervention (BEHAVIORAL), Exercise Intervention (BEHAVIORAL), FitBit (DEVICE).
Who is sponsoring clinical trial NCT05054296?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05054296 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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