Status:
RECRUITING
Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Pfizer
Prostate Cancer Foundation
Conditions:
Androgen Deprivation Therapy
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 dia...
Detailed Description
The research study procedures include: screening for eligibility, study intervention, and evaluation of blood markers (blood draw), body composition, cardiorespiratory fitness, muscular strength, and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05327465
Start Date
August 11 2022
End Date
June 30 2026
Last Update
January 27 2025
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215