Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy

Official title

Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy: POWER Trial

Overview

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.

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 surveys at study entry and follow-up visit.

Participants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.

* Aerobic and resistance exercise - virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom.The exercise group will be asked to perform exercise at home with virtual supervision, including aerobic exercise. The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer. * Usual care - maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise program after 16 weeks. The usual care group will be asked to maintain their current exercise levels and will be offered the same exercise intervention after the completion of the study.

All participants will undergo two testing visits throughout the 16-weeks of the study period, with the exercise group part-taking in 1 additional testing visit at week 8 to assess aerobic fitness and muscular strength only.

Participants will be on the research study for 4 months. It is expected that about 62 people will take part in this research study

Interventions

• Other Aerobic and resistance exercise
  Perform exercise at home with virtual supervision, including aerobic exercise (e.g.,cycling), which can improve cardiovascular (heart) and lung function, and resistance exercise (e.g., dumbbell lifting and using resistance band. The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer
• Other Usual Care
  Maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise (aerobic and resistance exercise) program after 16 weeks.

Primary outcome measures

• Cardiovascular disease risk factors [Time frame: baseline to 4 months]

Secondary outcome measures (12)

• Cardiorespiratory capacity [Time frame: baseline to 4 months]
• Muscular strength [Time frame: baseline to 4 months]
• Short Physical Performance Battery (SPPB) [Time frame: baseline to 4 months]
• Timed-Up-and-Go (TUG) [Time frame: baseline to 4 months]
• Hand grip strength [Time frame: baseline to 4 months]
• Fat mass [Time frame: baseline to 4 months]
• Percent body fat [Time frame: baseline to 4 months]
• Lean mass [Time frame: baseline to 4 months]
• Hip circumference [Time frame: baseline to 4 months]
• Waist circumference [Time frame: baseline to 4 months]
• Health-related quality of life - EORTC-QLQ C30 [Time frame: baseline to 4 months]
• Prostate cancer-specific symptoms - EPIC-26 [Time frame: baseline to 4 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Dana Farber Cancer Institute — Boston

Publications

• Kang DW, Ficarra S, Wilson RL, Morgans AK, Nguyen PL, Rebbeck TR, Einstein DJ, Uno H, Mossanen M, Hill DM, Gonzalo-Encabo P, Norris MK, Gardiner J, Tjogas D, Greer J, Dieli-Conwright CM. Exercise to enhance cardiovascular health among black men with prostate cancer with androgen deprivation therapy (the POWER trial): A study protocol. Contemp Clin Trials. 2025 Aug;155:107973. doi: 10.1016/j.cct.20 PMID 40451460

Identifiers

NCT: NCT05327465 · 21-741

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗