An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy

NCT ID: NCT02248350

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-09-30

Brief Summary

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.

Detailed 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.

Conditions

Prostate Cancer; Physical Activity; Side-effects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Exercise Group

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

Group Type: EXPERIMENTAL

Supervised and Home Based Exercise

Intervention Type: BEHAVIORAL

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.

Stretching Control group

Informational booklet containing stretching exercises (20-minutes a day)

Group Type: ACTIVE_COMPARATOR

Stretching Control Group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Office of Minority Health and Health Disparities Research

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

Georgetown_University_MC

Identifier Type: -

Identifier Source: org_study_id