Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy
Recruiting · NCT05327465 · Interventional (participants receive a specific treatment) · Lead sponsor: Dana-Farber Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
Aerobic and resistance exerciseUsual Care
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Dana Farber Cancer Institute - Boston, Massachusetts, United States