Exercise program to improve heart health in Black men with prostate cancer on hormone therapy
Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy: POWER Trial
NA · Dana-Farber Cancer Institute · NCT05327465
This study is testing whether a special exercise program can help improve heart health and overall well-being in Black men with prostate cancer who are receiving hormone therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Dana-Farber Cancer Institute (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05327465 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of a 16-week culturally tailored, technology-based exercise intervention on cardiovascular health among Black men diagnosed with prostate cancer who are undergoing androgen deprivation therapy (ADT). Participants will be randomly assigned to either an aerobic and resistance exercise group, which will receive virtual supervision, or a usual care group that maintains their baseline exercise levels. The study will assess various health markers, including blood tests, body composition, and physical fitness, at the beginning and end of the intervention. The goal is to determine if the exercise program can enhance physical fitness, quality of life, and self-esteem while reducing cardiovascular risk factors.
Who should consider this trial
Good fit: Ideal candidates are Black men over 18 years old who have been diagnosed with localized or metastatic prostate cancer and are currently receiving androgen deprivation therapy.
Not a fit: Patients with medical conditions that could worsen with exercise or those who are not medically cleared to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cardiovascular health and overall well-being for Black men undergoing ADT for prostate cancer.
How similar studies have performed: While similar exercise interventions have shown promise in improving health outcomes in cancer patients, this specific approach tailored for Black men on ADT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must meet all criteria to be eligible, including travel to Dana-Farber Cancer Institute (DFCI) to collect research data to address the study question. * Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease * Histologically diagnosed of localized or metastatic prostate cancer * Have been receiving androgen deprivation therapy (ADT) (i.e., luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist and/or androgen receptor \[AR\] agonist/antagonist) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment * Self-identify as Black * Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist * Are without medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases * Speak English and/or Spanish * Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week * Willing to travel to DFCI for necessary data collection * Ability to communicate and complete written forms in English and/or Spanish Exclusion Criteria: * Are not receiving ADT (i.e., LHRH agonist/antagonist and/or AR agonist/antagonist) * Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise * Are not English or Spanish speaking * Patients with secondary diagnosis (with the exception of basal cell carcinoma) * Participate in more than 60 minutes of moderate or vigorous structured exercise/week * Unable to travel to DFCI for necessary data collection * May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.
Where this trial is running
Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Christina C Dieli-Conwright, PhD, MPH — Dana-Farber Cancer Institute
- Study coordinator: Christina Dieli-Conwright, PhD, MPH
- Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
- Phone: 617-632-3800
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.
Conditions: Androgen Deprivation Therapy, Prostate Cancer, Prostate Cancer Metastatic, Androgen deprivation therapy, Localized Prostate Cancer, Exercise