This trial is active, not recruiting.

Conditions prostate cancer, physical activity, side-effects
Treatments supervised and home based exercise, stretching control group
Phase phase 1/phase 2
Sponsor Georgetown University
Collaborator American Cancer Society, Inc.
Start date September 2014
End date September 2017
Trial size 50 participants
Trial identifier NCT02248350, Georgetown_University_MC


This main purpose of this study is to examine the effects of an exercise intervention to counteract adverse side effects related to Androgen Deprivation Therapy (ADT) in prostate cancer patients. Specifically, a supervised and home-based exercise program will be used to assess its impact on clinical and behavioral variables related to ADT in prostate cancer patients.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
8-weeks of supervised and home based exercise intervention, 3 times a week, 50-minutes a session for a total of 150/minutes a week
supervised and home based exercise
Participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise for 8-weeks. The exercise intensity will be tailored between 60-80% of their VO2max, as determined during baseline testing and with a rating of perceived exertion (RPE) of 11-14 on the 20-point scale.
(Active Comparator)
Informational booklet containing stretching exercises (20-minutes a day)
stretching control group
Participants randomized into the control group will be provided an informational booklet with stretching techniques and exercises and will be asked to stretch at least 20-minutes a day for the duration of the study.

Primary Outcomes

Bone Mineral Density
time frame: 8-weeks

Secondary Outcomes

Physical Fitness
time frame: 8-weeks
Muscle strength
time frame: 8-weeks
Step Count
time frame: 8-weeks
Quality of Life (HRQOL)
time frame: 8-weeks
Hip/Waist Circumference
time frame: 8-weeks
Body Mass Index (BMI)
time frame: 8-weeks
Glucose/Lipid levels
time frame: 8-weeks

Eligibility Criteria

Male participants from 40 years up to 70 years old.

Inclusion Criteria: - (1) Caucasian or African-American/Black men; (2) histologically confirmed non-metastatic PCa; (3) receiving ADT treatment for 9-months or less upon recruitment (and continue to receive treatment during the duration of the study); (4) 40 to 75 years old; (5) sedentary defined as <60 minutes of recreation or work requiring modest PA/week; (6) ability to perform the level of physical activity assessed by the Physical Activity Readiness Questionnaire (PAR-Q); (6) has access to a smartphone or computer with internet capabilities Exclusion Criteria: - (1) severe cardiac disease; (2) recent myocardial infarction; (3) treated for any other cancer; (4) any physical, psychological illness, and/or medical problems that restricted them from exercise; (5) and not willing or able to follow procedures specified by the study and/or instructions of the researcher.

Additional Information

Official title An Exercise Intervention to Mitigate Side-Effects Related to Androgen Deprivation Therapy Among Prostate Cancer Survivors.
Description This study will assess the feasibility of an exercise intervention to counteract adverse side effects related to ADT in prostate cancer (PCa) patients. Specifically, we will use an exercise intervention and assess its impact on bone mass density, Body Mass Index (BMI), hip/waist circumference levels, biomarkers (i.e., glucose, lipids), step count, grip strength, and health-related quality of life (HRQOL) using the Patient Reported Outcomes Measurement Information System (PROMIS®). In this 8-week two-arm randomized clinical trial, 40 PCa patients receiving ADT will be randomly assigned to an exercise (n=20) or a stretching control group (n=20) with a follow-up at 8-weeks.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Georgetown University.