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

Primary Purpose

Androgen Deprivation Therapy, Prostate Cancer, Prostate Cancer Metastatic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic and resistance exercise
Usual Care
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Androgen Deprivation Therapy focused on measuring Androgen deprivation therapy, Localized Prostate Cancer, Prostate Cancer Metastatic, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic and resistance exercise

Usual care

Arm Description

Virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom. The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer.

Maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise program after 16 weeks.

Outcomes

Primary Outcome Measures

Cardiovascular disease risk factors
Framingham Risk Score, an established comprehensive tool for evaluating the risk of developing cardiovascular disease using blood samples (i.e., low-density lipoprotein-cholesterol [LDL-C] or total cholesterol [TC], high-density lipoprotein-cholesterol [HDL-C]), demographic and medical profiles , and lifestyle behaviors (i.e., age, blood pressure, and diabetic and smoking status). The score ranges from -4 to 36 and the 10-year cardiovascular risk will be calculated accordingly (a higher score indicates a higher risk of cardiovascular disease).

Secondary Outcome Measures

Cardiorespiratory capacity
Cardiorespiratory fitness will be assessed as VO2peak by a graded maximal cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged among every 15-second interval during the test. VO2peak will be reported in both relative (ml·kg-1·min-1) and absolute (L/min) terms
Muscular strength
Muscular strength will be measured as 1-repetition maximum (RM) (i.e., the greatest resistance that can be moved through the full range of motion), which has been the standard for strength assessments. 1-RM values will be estimated from 10-RM using validated equations on 12 exercises including the ten exercises utilized in the prescription not performed on machines.
Short Physical Performance Battery (SPPB)
Physical function will be assessed by the SPPB. This includes the following 3 lower extremity measures completed in the following order. Timed balance (seconds): Balance will be assessed under 3 conditions (side-by-side, semi-tandem, and tandem stands). Gait speed (seconds): Gait speed will be assessed over a 4-meter flat surface distance. The participant will be asked to complete 2 attempts of this test. Time will be recorded using an electronic timing system. Chair stand (seconds): Chair stand will be performed under 2 conditions: a) subjects will perform a single chair stand; b) subjects will be asked to perform 5 repeated chair stands as quickly as possible; time to completion will be recorded.
Timed-Up-and-Go (TUG)
Mobility will be assessed using the Timed Up and Go (TUG) test, which has been shown to predict immediate fall risk better than static balance tests or isometric muscle strength. Participants begin seated in a chair with hands on the armrests, are asked to rise, walk to a line on the floor 3 m from the chair, turn around, and return to the same seated position as quickly and safe as possible. Scores will be taken as the time (seconds) to complete the task, with one practice trial given. An average of time for 3 trials is calculated.
Hand grip strength
Grip strength will be measured using a hand-held dynamometer on the participant's dominant hand. The subject will be asked to grip the handle of the dynamometer with one hand using as much grip pressure (kg) as possible while holding for 2 seconds. The subject will be asked to complete 2 grip strength attempts.
Fat mass
Fat mass (kg) will be obtained from a whole-body dual-energy x-ray absorptiometry scan (DXA; Lunar DPX-IQ), which provides highly accurate results compared to computed tomography, a gold standard measure of body composition.
Percent body fat
Percent body fat will be obtained from a whole-body dual-energy x-ray absorptiometry scan (DXA; Lunar DPX-IQ), which provides highly accurate results compared to computed tomography, a gold standard measure of body composition.
Lean mass
Lean mass (kg) will be obtained from a whole-body dual-energy x-ray absorptiometry scan (DXA; Lunar DPX-IQ), which provides highly accurate results compared to computed tomography, a gold standard measure of body composition.
Hip circumference
A constant-tension tape measure will be used to obtain waist circumference (i.e., the distance around the waist using the umbilicus as the reference point) (cm).
Waist circumference
A constant-tension tape measure will be used to obtain hip circumference (the distance around the widest girth of the buttocks using the greater trochanter as a landmark) (cm).
Health-related quality of life - EORTC-QLQ C30
European Organization for Research and Treatment of Cancer- Quality of Life Questionnaire-C30 will assess health-related quality of life, consisting of substacles including functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures. The score ranges from 0 to 100 and a higher value indicates a better quality of life.
Prostate cancer-specific symptoms - EPIC-26
Expanded Prostate Cancer Index Composite-26 will assess prostate cancer-specific symptoms (e.g., urinary incontinence, sexual dysfunction, and bowel dysfunction). The score ranges from 0 to 100 and a higher value indicates a worse symptom.
Cancer treatment symptoms - MDASI
MD Anderson Symptom Inventory will assess cancer treatment symptoms (e.g., pain, neuropathy). The score ranges from 0 to 10 and a higher value indicates a worse symptom.
Self-esteem - RSES
The Rosenberg Self-Esteem Scale will assess self-esteem. The score ranges from 10 to 40 and a higher value indicates a better self-esteem.
Percieved implementation outcomes assessed by AIM, IAM, and FIM
The Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure will be assessed at post-intervention to measure participant-perceived intervention feasibility and acceptability. Each measure has four items with 5-point likers scale. The values in each measure will be the mean of four items and range from 5-20. A higher value means a more acceptable, appropriate, and feasible intervention, perceived by participants, respectively.

Full Information

First Posted
March 16, 2022
Last Updated
July 20, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Pfizer, Prostate Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05327465
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Pfizer, Prostate Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgen Deprivation Therapy, Prostate Cancer, Prostate Cancer Metastatic
Keywords
Androgen deprivation therapy, Localized Prostate Cancer, Prostate Cancer Metastatic, Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic and resistance exercise
Arm Type
Experimental
Arm Description
Virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom. The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise program after 16 weeks.
Intervention Type
Other
Intervention Name(s)
Aerobic and resistance exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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 Measure Information:
Title
Cardiovascular disease risk factors
Description
Framingham Risk Score, an established comprehensive tool for evaluating the risk of developing cardiovascular disease using blood samples (i.e., low-density lipoprotein-cholesterol [LDL-C] or total cholesterol [TC], high-density lipoprotein-cholesterol [HDL-C]), demographic and medical profiles , and lifestyle behaviors (i.e., age, blood pressure, and diabetic and smoking status). The score ranges from -4 to 36 and the 10-year cardiovascular risk will be calculated accordingly (a higher score indicates a higher risk of cardiovascular disease).
Time Frame
baseline to 4 months
Secondary Outcome Measure Information:
Title
Cardiorespiratory capacity
Description
Cardiorespiratory fitness will be assessed as VO2peak by a graded maximal cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged among every 15-second interval during the test. VO2peak will be reported in both relative (ml·kg-1·min-1) and absolute (L/min) terms
Time Frame
baseline to 4 months
Title
Muscular strength
Description
Muscular strength will be measured as 1-repetition maximum (RM) (i.e., the greatest resistance that can be moved through the full range of motion), which has been the standard for strength assessments. 1-RM values will be estimated from 10-RM using validated equations on 12 exercises including the ten exercises utilized in the prescription not performed on machines.
Time Frame
baseline to 4 months
Title
Short Physical Performance Battery (SPPB)
Description
Physical function will be assessed by the SPPB. This includes the following 3 lower extremity measures completed in the following order. Timed balance (seconds): Balance will be assessed under 3 conditions (side-by-side, semi-tandem, and tandem stands). Gait speed (seconds): Gait speed will be assessed over a 4-meter flat surface distance. The participant will be asked to complete 2 attempts of this test. Time will be recorded using an electronic timing system. Chair stand (seconds): Chair stand will be performed under 2 conditions: a) subjects will perform a single chair stand; b) subjects will be asked to perform 5 repeated chair stands as quickly as possible; time to completion will be recorded.
Time Frame
baseline to 4 months
Title
Timed-Up-and-Go (TUG)
Description
Mobility will be assessed using the Timed Up and Go (TUG) test, which has been shown to predict immediate fall risk better than static balance tests or isometric muscle strength. Participants begin seated in a chair with hands on the armrests, are asked to rise, walk to a line on the floor 3 m from the chair, turn around, and return to the same seated position as quickly and safe as possible. Scores will be taken as the time (seconds) to complete the task, with one practice trial given. An average of time for 3 trials is calculated.
Time Frame
baseline to 4 months
Title
Hand grip strength
Description
Grip strength will be measured using a hand-held dynamometer on the participant's dominant hand. The subject will be asked to grip the handle of the dynamometer with one hand using as much grip pressure (kg) as possible while holding for 2 seconds. The subject will be asked to complete 2 grip strength attempts.
Time Frame
baseline to 4 months
Title
Fat mass
Description
Fat mass (kg) will be obtained from a whole-body dual-energy x-ray absorptiometry scan (DXA; Lunar DPX-IQ), which provides highly accurate results compared to computed tomography, a gold standard measure of body composition.
Time Frame
baseline to 4 months
Title
Percent body fat
Description
Percent body fat will be obtained from a whole-body dual-energy x-ray absorptiometry scan (DXA; Lunar DPX-IQ), which provides highly accurate results compared to computed tomography, a gold standard measure of body composition.
Time Frame
baseline to 4 months
Title
Lean mass
Description
Lean mass (kg) will be obtained from a whole-body dual-energy x-ray absorptiometry scan (DXA; Lunar DPX-IQ), which provides highly accurate results compared to computed tomography, a gold standard measure of body composition.
Time Frame
baseline to 4 months
Title
Hip circumference
Description
A constant-tension tape measure will be used to obtain waist circumference (i.e., the distance around the waist using the umbilicus as the reference point) (cm).
Time Frame
baseline to 4 months
Title
Waist circumference
Description
A constant-tension tape measure will be used to obtain hip circumference (the distance around the widest girth of the buttocks using the greater trochanter as a landmark) (cm).
Time Frame
baseline to 4 months
Title
Health-related quality of life - EORTC-QLQ C30
Description
European Organization for Research and Treatment of Cancer- Quality of Life Questionnaire-C30 will assess health-related quality of life, consisting of substacles including functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures. The score ranges from 0 to 100 and a higher value indicates a better quality of life.
Time Frame
baseline to 4 months
Title
Prostate cancer-specific symptoms - EPIC-26
Description
Expanded Prostate Cancer Index Composite-26 will assess prostate cancer-specific symptoms (e.g., urinary incontinence, sexual dysfunction, and bowel dysfunction). The score ranges from 0 to 100 and a higher value indicates a worse symptom.
Time Frame
baseline to 4 months
Title
Cancer treatment symptoms - MDASI
Description
MD Anderson Symptom Inventory will assess cancer treatment symptoms (e.g., pain, neuropathy). The score ranges from 0 to 10 and a higher value indicates a worse symptom.
Time Frame
baseline to 4 months
Title
Self-esteem - RSES
Description
The Rosenberg Self-Esteem Scale will assess self-esteem. The score ranges from 10 to 40 and a higher value indicates a better self-esteem.
Time Frame
baseline to 4 months
Title
Percieved implementation outcomes assessed by AIM, IAM, and FIM
Description
The Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure will be assessed at post-intervention to measure participant-perceived intervention feasibility and acceptability. Each measure has four items with 5-point likers scale. The values in each measure will be the mean of four items and range from 5-20. A higher value means a more acceptable, appropriate, and feasible intervention, perceived by participants, respectively.
Time Frame
baseline to 4 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Dieli-Conwright, PhD, MPH
Phone
617-632-3800
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina C Dieli-Conwright, PhD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD, MPH
Phone
617-632-3800
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
PhD, MPH
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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

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