Clinical trial NCT03070145: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Change from Baseline in Physical Performance at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from Baseline in Physiologic Measurements at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from Baseline in Blood Pressure at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from Baseline in Body Composition at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: Baseline and 12 weeks
measure: Physical Functioning
timeFrame: Baseline and 12 weeks
measure: Minutes of Physical Activity
timeFrame: Baseline and 12 weeks
measure: Anthropometric Measures
timeFrame: Baseline and 12 weeks
measure: Anthropometric Measures
timeFrame: Baseline and 12 weeks
measure: Anthropometric Measures
timeFrame: Baseline and 12 weeks.
measure: Biomarkers
timeFrame: Baseline and 12 weeks.
measure: Biomarkers
timeFrame: Baseline and 12 weeks.
measure: Measure adherence
timeFrame: Baseline and 12 weeks
measure: Measure feasibility
timeFrame: Baseline and 12 weeks
measure: Measure feasibility
timeFrame: Baseline and 12 weeks
measure: Measure feasibility
timeFrame: Baseline and 12 weeks
measure: Measure feasibility
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Paul L. Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: