Clinical trial NCT05327465: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Androgen Deprivation Therapy
Prostate Cancer
Prostate Cancer Metastatic
Keywords: Androgen deprivation therapy
Localized Prostate Cancer
Prostate Cancer Metastatic
Exercise
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Prostate Cancer Foundation
First posted: 2022-04-14
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

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.

Primary outcomes:
measure: Cardiovascular disease risk factors
timeFrame: baseline to 4 months
Secondary outcomes:
measure: Cardiorespiratory capacity
timeFrame: baseline to 4 months
measure: Muscular strength
timeFrame: baseline to 4 months
measure: Short Physical Performance Battery (SPPB)
timeFrame: baseline to 4 months
measure: Timed-Up-and-Go (TUG)
timeFrame: baseline to 4 months
measure: Hand grip strength
timeFrame: baseline to 4 months
measure: Fat mass
timeFrame: baseline to 4 months
measure: Percent body fat
timeFrame: baseline to 4 months
measure: Lean mass
timeFrame: baseline to 4 months
measure: Hip circumference
timeFrame: baseline to 4 months
measure: Waist circumference
timeFrame: baseline to 4 months
measure: Health-related quality of life - EORTC-QLQ C30
timeFrame: baseline to 4 months
measure: Prostate cancer-specific symptoms - EPIC-26
timeFrame: baseline to 4 months
measure: Cancer treatment symptoms - MDASI
timeFrame: baseline to 4 months
measure: Self-esteem - RSES
timeFrame: baseline to 4 months
measure: Percieved implementation outcomes assessed by AIM, IAM, and FIM
timeFrame: baseline to 4 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina C Dieli-Conwright, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: