NCT05327465 Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy
| NCT ID | NCT05327465 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Androgen Deprivation Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2022-08-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2022-08-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research is to determine whether a 16-week culturally tailored, technology-based, aerobic and resistance exercise intervention improves cardiovascular risk factors in Black men diagnosed with prostate cancer and are undergoing androgen deprivation therapy (ADT), and whether it will also improve physical fitness and function, body composition, and outcomes such as quality of life, cancer symptoms, and self-esteem. Participants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.
Eligibility 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.
Contact & Investigator
Christina C Dieli-Conwright, PhD, MPH
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT05327465 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Androgen Deprivation Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05327465 currently recruiting?
Yes, NCT05327465 is actively recruiting participants. Contact the research team at ChristinaM_Dieli-Conwright@dfci.harvard.edu for enrollment information.
Where is the NCT05327465 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05327465 clinical trial?
NCT05327465 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Christina C Dieli-Conwright, PhD, MPH at Dana-Farber Cancer Institute. The trial plans to enroll 62 participants.