search
Back to results

Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent prior to any study-related procedures
  • History of histologically confirmed prostate cancer
  • Initiating or within 30 days of initiating ADT
  • ECOG performance status of 0 or 1
  • At least 18 years old and no older than 80 years
  • Physically able to exercise and have physician consent from their treating physician to start a physical activity program
  • English speaking and able to read English
  • Have access to and are able to use the internet at a minimum of once per week
  • Sufficient proficiency and confidence to use the internet and follow video-based instructions, as determined by the eligibility questionnaire to be completed by the participant
  • Willingness to be randomized

Exclusion Criteria:

  • Self-reported inability to walk 2 blocks (at any pace)
  • Currently physically active (> 90 minutes of moderate or vigorous physical activity per week) as determined by Leisure Score Index of Godin Leisure-Time Exercise Questionnaire [LSI])
  • Previously on ADT
  • Radiologic evidence of distant disease
  • Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
  • Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder)

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Intervention

Usual Care

Arm Description

12-weeks brisk walking and strength training 150 minute moderate aerobic activities, such as brisk walking Strength training 3 days /week One on one sessions with exercise physiologist Optional group sessions

Usual Care provided

Outcomes

Primary Outcome Measures

Change from Baseline in Physical Performance at 12 weeks
The 6 Minute Walk Test will be performed at the clinic, where the participants will wear tennis shoes and will walk indoors on a flat surface for 6 minutes.
Change from Baseline in Physiologic Measurements at 12 weeks
Measuring heart rate and resting pulse by counting the number of beats per minute at the wrist of each participant.
Change from Baseline in Blood Pressure at 12 weeks
The investigators will obtain participant's blood pressure from the most recent clinical visit.
Change from Baseline in Body Composition at 12 weeks
Obtain body composition (total fat and lean body mass) by conducting dual energy X-ray absorptiometry (DEXA) scans.

Secondary Outcome Measures

Fatigue
The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function.
Physical Functioning
The investigators will assess changes in physical functioning from study enrollment to the completion of the study period using the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3) and the Prostate Cancer Specific EORTC questionnaire.
Minutes of Physical Activity
The investigators will assess changes in activity from baseline to 12-weeks using the 7-Day Physical Activity Recall (PAR)
Anthropometric Measures
The investigators will assess changes in height from baseline to 12 weeks using a tape measure.
Anthropometric Measures
The investigators will assess changes in weight from baseline to 12 weeks using a scale.
Anthropometric Measures
The investigators will assess changes in waist circumference from baseline to 12 weeks using a tape measure.
Biomarkers
The investigators will assess PSA at baseline and 12-weeks in both the usual care and intervention arm.
Biomarkers
The investigators will assess testosterone levels at baseline and 12-weeks in both the usual care and intervention arm.
Measure adherence
The investigators will evaluate adherence rates to study procedures by using self-report and FitBit
Measure feasibility
Feasibility measured by number of eligible members of the targeted population
Measure feasibility
Feasibility measured by recruitment rates
Measure feasibility
Feasibility measured by refusal rates for participation and randomization
Measure feasibility
Feasibility measured by level of engagement with Postwire and with other study participants.

Full Information

First Posted
February 6, 2017
Last Updated
September 21, 2021
Sponsor
Dana-Farber Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03070145
Brief Title
Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy
Official Title
Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 8, 2017 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
December 12, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This research study is evaluating the impact and feasibility of a 12-week brisk walking and moderate strength training exercise intervention including a virtual component in men who are initiating androgen deprivation therapy (ADT) for prostate cancer
Detailed Description
Androgen deprivation therapy (ADT) is a key treatment of prostate cancer. While this therapy improves prostate cancer outcomes, ADT also has a variety of short- and long-term adverse effects, including increased body weight, loss of lean muscle mass, reductions in quality of life, and increased risk of cardiovascular disease. Studies have shown that among men with prostate cancer, physical activity is associated with improved outcomes, including a reduced risk of mortality, from prostate cancer and other causes. Our hypothesis is that physical activity will improve some of the physical and emotional side effects associated with ADT. Physical activity, such as brisk walking and moderate strength training, offers a lifestyle factor that may improve some of the side effects, and is low-cost and easy to do. The investigators are conducting this study to evaluate the impact and feasibility of a 12-week moderate-intensity aerobic and strength training exercise intervention, including a virtual component. The intervention includes brisk walking and moderate strength training, and involves home-based exercises, in-person sessions with an oncology-trained exercise physiologist, optional group training sessions, and weekly training goals. Participants will have access to a personalized web-based platform called Postwire, which will include videos of training sessions, and will allow participants to easily communicate with the study staff and with other study participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention
Arm Type
Experimental
Arm Description
12-weeks brisk walking and strength training 150 minute moderate aerobic activities, such as brisk walking Strength training 3 days /week One on one sessions with exercise physiologist Optional group sessions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care provided
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
12-week moderate-intensity aerobic and strength training exercise intervention
Primary Outcome Measure Information:
Title
Change from Baseline in Physical Performance at 12 weeks
Description
The 6 Minute Walk Test will be performed at the clinic, where the participants will wear tennis shoes and will walk indoors on a flat surface for 6 minutes.
Time Frame
Baseline and 12 weeks
Title
Change from Baseline in Physiologic Measurements at 12 weeks
Description
Measuring heart rate and resting pulse by counting the number of beats per minute at the wrist of each participant.
Time Frame
Baseline and 12 weeks
Title
Change from Baseline in Blood Pressure at 12 weeks
Description
The investigators will obtain participant's blood pressure from the most recent clinical visit.
Time Frame
Baseline and 12 weeks
Title
Change from Baseline in Body Composition at 12 weeks
Description
Obtain body composition (total fat and lean body mass) by conducting dual energy X-ray absorptiometry (DEXA) scans.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Fatigue
Description
The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function.
Time Frame
Baseline and 12 weeks
Title
Physical Functioning
Description
The investigators will assess changes in physical functioning from study enrollment to the completion of the study period using the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3) and the Prostate Cancer Specific EORTC questionnaire.
Time Frame
Baseline and 12 weeks
Title
Minutes of Physical Activity
Description
The investigators will assess changes in activity from baseline to 12-weeks using the 7-Day Physical Activity Recall (PAR)
Time Frame
Baseline and 12 weeks
Title
Anthropometric Measures
Description
The investigators will assess changes in height from baseline to 12 weeks using a tape measure.
Time Frame
Baseline and 12 weeks
Title
Anthropometric Measures
Description
The investigators will assess changes in weight from baseline to 12 weeks using a scale.
Time Frame
Baseline and 12 weeks
Title
Anthropometric Measures
Description
The investigators will assess changes in waist circumference from baseline to 12 weeks using a tape measure.
Time Frame
Baseline and 12 weeks.
Title
Biomarkers
Description
The investigators will assess PSA at baseline and 12-weeks in both the usual care and intervention arm.
Time Frame
Baseline and 12 weeks.
Title
Biomarkers
Description
The investigators will assess testosterone levels at baseline and 12-weeks in both the usual care and intervention arm.
Time Frame
Baseline and 12 weeks.
Title
Measure adherence
Description
The investigators will evaluate adherence rates to study procedures by using self-report and FitBit
Time Frame
Baseline and 12 weeks
Title
Measure feasibility
Description
Feasibility measured by number of eligible members of the targeted population
Time Frame
Baseline and 12 weeks
Title
Measure feasibility
Description
Feasibility measured by recruitment rates
Time Frame
Baseline and 12 weeks
Title
Measure feasibility
Description
Feasibility measured by refusal rates for participation and randomization
Time Frame
Baseline and 12 weeks
Title
Measure feasibility
Description
Feasibility measured by level of engagement with Postwire and with other study participants.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent prior to any study-related procedures History of histologically confirmed prostate cancer Initiating or within 30 days of initiating ADT ECOG performance status of 0 or 1 At least 18 years old and no older than 80 years Physically able to exercise and have physician consent from their treating physician to start a physical activity program English speaking and able to read English Have access to and are able to use the internet at a minimum of once per week Sufficient proficiency and confidence to use the internet and follow video-based instructions, as determined by the eligibility questionnaire to be completed by the participant Willingness to be randomized Exclusion Criteria: Self-reported inability to walk 2 blocks (at any pace) Currently physically active (> 90 minutes of moderate or vigorous physical activity per week) as determined by Leisure Score Index of Godin Leisure-Time Exercise Questionnaire [LSI]) Previously on ADT Radiologic evidence of distant disease Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility. Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul L. Nguyen, MD
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy

We'll reach out to this number within 24 hrs