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Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy

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ClinicalTrials.gov Identifier: NCT03070145
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Paul Nguyen, MD, Dana-Farber Cancer Institute

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Exercise Intervention Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy: A Pilot Study
Actual Study Start Date : December 8, 2017
Estimated Primary Completion Date : February 25, 2020
Estimated Study Completion Date : February 25, 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
Other: Exercise Intervention
12-week moderate-intensity aerobic and strength training exercise intervention
No Intervention: Usual Care
Usual Care provided



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. Anthropometric Measures [ Time Frame: Baseline and 12 weeks ]
    The investigators will assess changes in height from baseline to 12 weeks using a tape measure.

  5. Anthropometric Measures [ Time Frame: Baseline and 12 weeks ]
    The investigators will assess changes in weight from baseline to 12 weeks using a scale.

  6. 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.

  7. 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.

  8. 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.

  9. Feasibility [ Time Frame: Baseline and 12 weeks ]
    The investigators will evaluate adherence rates to study procedures.

  10. Feasibility [ Time Frame: Baseline and 12 weeks ]
    Feasibility measured by number of eligible members of the targeted population

  11. Feasibility [ Time Frame: Baseline and 12 weeks ]
    Feasibility measured by recruitment rates

  12. Feasibility [ Time Frame: Baseline and 12 weeks ]
    Feasibility measured by refusal rates for participation and randomization

  13. Feasibility [ Time Frame: Baseline and 12 weeks ]
    Feasibility measured by level of engagement with Postwire and with other study participants.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070145


Contacts
Contact: Ninjin Boldbaatar, MPH 617-582-8918 nboldbaatar@bwh.harvard.edu
Contact: Paul L. Nguyen, MD 617-732-7936 PNGUYEN@lroc.harvard.edu

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Paul Nguyen, MD    617-732-7936    PNGUYEN@lroc.harvard.edu   
Principal Investigator: Paul Nguyen, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Paul L. Nguyen, MD Dana-Farber Cancer Institute

Responsible Party: Paul Nguyen, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03070145     History of Changes
Other Study ID Numbers: 16-515
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Paul Nguyen, MD, Dana-Farber Cancer Institute:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs