Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:10/14/2018
Start Date:December 8, 2017
End Date:February 25, 2022
Contact:Elizabeth Jiang
Email:elizabeth_jiang@dfci.harvard.edu
Phone:617-582-8939

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Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy: A Pilot Study

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

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.

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)
We found this trial at
1
site
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Paul Nguyen, MD
Phone: 617-732-7936
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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