Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy

NCT03070145 | Completed DMC

• 1 other identifier: 16-515
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Physical Performance at 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

  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

  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

  Obtain body composition (total fat and lean body mass) by conducting dual energy X-ray absorptiometry (DEXA) scans.

  Baseline and 12 weeks

Secondary Outcomes (13)

• Fatigue

  Baseline and 12 weeks

• Physical Functioning

  Baseline and 12 weeks

• Minutes of Physical Activity

  Baseline and 12 weeks

• Anthropometric Measures

  Baseline and 12 weeks

• Anthropometric Measures

  Baseline and 12 weeks

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

* 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

Usual Care

NO INTERVENTION

Usual Care provided

Interventions

Exercise Intervention OTHER

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

Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Paul L. Nguyen, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: March 3, 2017
• Study Start: December 8, 2017
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)