Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy

• ClinicalTrials.gov Identifier: NCT03070145
• Recruitment Status: Completed
• First Posted: March 3, 2017
• Last Update Posted: September 22, 2021
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Paul Nguyen, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: February 6, 2017
• First Posted Date: March 3, 2017
• Last Update Posted Date: September 22, 2021
• Actual Study Start Date: December 8, 2017
• Actual Primary Completion Date: December 12, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 28, 2017)

• 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.
• Change from Baseline in Physiologic Measurements at 12 weeks [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 12 weeks ]
  Obtain body composition (total fat and lean body mass) by conducting dual energy X-ray absorptiometry (DEXA) scans.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 28, 2018)

• 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.
• 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.
• Minutes of Physical Activity [ Time Frame: Baseline and 12 weeks ]
  The investigators will assess changes in activity from baseline to 12-weeks using the 7-Day Physical Activity Recall (PAR)
• Anthropometric Measures [ Time Frame: Baseline and 12 weeks ]
  The investigators will assess changes in height from baseline to 12 weeks using a tape measure.
• Anthropometric Measures [ Time Frame: Baseline and 12 weeks ]
  The investigators will assess changes in weight from baseline to 12 weeks using a scale.
• Anthropometric Measures [ Time Frame: Baseline and 12 weeks. ]
  The investigators will assess changes in waist circumference from baseline to 12 weeks using a tape measure.
• 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.
• 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.
• Measure adherence [ Time Frame: Baseline and 12 weeks ]
  The investigators will evaluate adherence rates to study procedures by using self-report and FitBit
• Measure feasibility [ Time Frame: Baseline and 12 weeks ]
  Feasibility measured by number of eligible members of the targeted population
• Measure feasibility [ Time Frame: Baseline and 12 weeks ]
  Feasibility measured by recruitment rates
• Measure feasibility [ Time Frame: Baseline and 12 weeks ]
  Feasibility measured by refusal rates for participation and randomization
• Measure feasibility [ Time Frame: Baseline and 12 weeks ]
  Feasibility measured by level of engagement with Postwire and with other study participants.

Original Secondary Outcome Measures (submitted: February 28, 2017)

• 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.
• 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.
• Minutes of Physical Activity [ Time Frame: Baseline and 12 weeks ]
  The investigators will assess changes in activity from baseline to 12-weeks using the 7-Day Physical Activity Recall (PAR)
• Anthropometric Measures [ Time Frame: Baseline and 12 weeks ]
  The investigators will assess changes in height from baseline to 12 weeks using a tape measure.
• Anthropometric Measures [ Time Frame: Baseline and 12 weeks ]
  The investigators will assess changes in weight from baseline to 12 weeks using a scale.
• Anthropometric Measures [ Time Frame: Baseline and 12 weeks. ]
  The investigators will assess changes in waist circumference from baseline to 12 weeks using a tape measure.
• 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.
• 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.
• Feasibility [ Time Frame: Baseline and 12 weeks ]
  The investigators will evaluate adherence rates to study procedures.
• Feasibility [ Time Frame: Baseline and 12 weeks ]
  Feasibility measured by number of eligible members of the targeted population
• Feasibility [ Time Frame: Baseline and 12 weeks ]
  Feasibility measured by recruitment rates
• Feasibility [ Time Frame: Baseline and 12 weeks ]
  Feasibility measured by refusal rates for participation and randomization
• Feasibility [ Time Frame: Baseline and 12 weeks ]
  Feasibility measured by level of engagement with Postwire and with other study participants.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Prostate Cancer

Intervention

Other: Exercise Intervention

12-week moderate-intensity aerobic and strength training exercise intervention

Study Arms

• Experimental: Exercise Intervention
  • 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
  Intervention: Other: Exercise Intervention
• No Intervention: Usual Care
  Usual Care provided

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 21, 2021): 13
• Original Estimated Enrollment (submitted: February 28, 2017): 40
• Actual Study Completion Date: December 12, 2019
• Actual Primary Completion Date: December 12, 2019 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03070145
• Other Study ID Numbers: 16-515
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Paul Nguyen, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Paul Nguyen, MD, Dana-Farber Cancer Institute, Paul L. Nguyen, MD
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Paul L. Nguyen, MD; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: September 2021