Home-based exercise program to lower heart disease risk in prostate cancer patients
Behavioral Exercise Training to Reduce Cardiovascular Disease Risk in Men Undergoing Androgen Deprivation Therapy (EXTRA-PC)
This study is testing whether a home-based exercise program can help improve the fitness and health of prostate cancer patients compared to a group that only receives healthy living tips.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | Male |
| Sponsor | Virginia Commonwealth University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Richmond, Virginia and 1 other locations) |
| Trial ID | NCT06237179 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a home-based exercise training intervention designed to improve exercise capacity in patients diagnosed with prostate cancer. Participants will engage in an exercise program and will be compared to a control group receiving healthy living education over a 12-week period. The primary outcomes measured will include improvements in VO2 peak and 6-minute walk distance. The study is designed to assess the feasibility and preliminary effectiveness of this intervention in enhancing the overall health of prostate cancer patients undergoing treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 40 to 85 diagnosed with stage II, III, or IV prostate cancer who are currently undergoing androgen deprivation therapy.
Not a fit: Patients with serious medical conditions that prevent safe participation in an exercise program or those with pre-existing cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the physical fitness and overall quality of life for prostate cancer patients.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in cancer patients, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be diagnosed with stage II/III/IV prostate cancer * Be currently undergoing treatment with ADT (intermittent or prolonged) * Have completed local curative-intent treatment, including prostatectomy or definitive radiation; * Be \>40 years of age up to 85; * Be willing to sign an informed consent with HIPAA authorization form; * Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation; * Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview; * Be without any serious medical condition that precludes safe participation in an exercise program; * Speak English Exclusion Criteria: * Be unable to undergo MRI (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia); * Have contraindications to exercise testing; * Have pre-existing overt cardiovascular disease/heart failure; * Active illness/infection; * Hemoglobin \< 7.0 grams/dL * Platelet count \< 10 x 109/L
Where this trial is running
Richmond, Virginia and 1 other locations
- Richmond Veterans Affairs Medical Center — Richmond, Virginia, United States (Not_yet_recruiting)
- Virginia Commonwealth University Massey Cancer Center — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Alexander R Lucas, PhD — Virginia Commonwealth University
- Study coordinator: Alexander R Lucas, PhD
- Email: Alexander.Lucas@vcuhealth.org
- Phone: 804 628-6610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.