- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03070145
Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy
Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy: A Pilot Study
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Exercise Intervention
|
12-week moderate-intensity aerobic and strength training exercise intervention
|
NO_INTERVENTION: Usual Care
Usual Care provided
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Physical Performance at 12 weeks
Time Frame: Baseline and 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.
|
Baseline and 12 weeks
|
Change from Baseline in Physiologic Measurements at 12 weeks
Time Frame: Baseline and 12 weeks
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Measuring heart rate and resting pulse by counting the number of beats per minute at the wrist of each participant.
|
Baseline and 12 weeks
|
Change from Baseline in Blood Pressure at 12 weeks
Time Frame: Baseline and 12 weeks
|
The investigators will obtain participant's blood pressure from the most recent clinical visit.
|
Baseline and 12 weeks
|
Change from Baseline in Body Composition at 12 weeks
Time Frame: Baseline and 12 weeks
|
Obtain body composition (total fat and lean body mass) by conducting dual energy X-ray absorptiometry (DEXA) scans.
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue
Time Frame: Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
Physical Functioning
Time Frame: Baseline and 12 weeks
|
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.
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Baseline and 12 weeks
|
Minutes of Physical Activity
Time Frame: Baseline and 12 weeks
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The investigators will assess changes in activity from baseline to 12-weeks using the 7-Day Physical Activity Recall (PAR)
|
Baseline and 12 weeks
|
Anthropometric Measures
Time Frame: Baseline and 12 weeks
|
The investigators will assess changes in height from baseline to 12 weeks using a tape measure.
|
Baseline and 12 weeks
|
Anthropometric Measures
Time Frame: Baseline and 12 weeks
|
The investigators will assess changes in weight from baseline to 12 weeks using a scale.
|
Baseline and 12 weeks
|
Anthropometric Measures
Time Frame: Baseline and 12 weeks.
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The investigators will assess changes in waist circumference from baseline to 12 weeks using a tape measure.
|
Baseline and 12 weeks.
|
Biomarkers
Time Frame: Baseline and 12 weeks.
|
The investigators will assess PSA at baseline and 12-weeks in both the usual care and intervention arm.
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Baseline and 12 weeks.
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Biomarkers
Time Frame: Baseline and 12 weeks.
|
The investigators will assess testosterone levels at baseline and 12-weeks in both the usual care and intervention arm.
|
Baseline and 12 weeks.
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Measure adherence
Time Frame: Baseline and 12 weeks
|
The investigators will evaluate adherence rates to study procedures by using self-report and FitBit
|
Baseline and 12 weeks
|
Measure feasibility
Time Frame: Baseline and 12 weeks
|
Feasibility measured by number of eligible members of the targeted population
|
Baseline and 12 weeks
|
Measure feasibility
Time Frame: Baseline and 12 weeks
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Feasibility measured by recruitment rates
|
Baseline and 12 weeks
|
Measure feasibility
Time Frame: Baseline and 12 weeks
|
Feasibility measured by refusal rates for participation and randomization
|
Baseline and 12 weeks
|
Measure feasibility
Time Frame: Baseline and 12 weeks
|
Feasibility measured by level of engagement with Postwire and with other study participants.
|
Baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-515
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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