An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Prostate Cancer Clinical Trial

— MIGHTY  

Official title:

An Exercise Intervention to Mitigate Side-Effects Related to Androgen Deprivation Therapy Among Prostate Cancer Survivors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248350
• Other study ID #: Georgetown_University_MC
• Status: Completed
• Phase: N/A
• First received: September 22, 2014
• Last updated: February 13, 2018
• Start date: September 2014
• Est. completion date: September 2017

Study information

• Verified date: July 2016
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Activity
• Prostate Cancer
• Prostatic Neoplasms
• Side-effects

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Office of Minority Health and Health Disparities Research	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density	BMD will be measured by a DXA scan	8-weeks
Secondary	Physical Fitness	. The Bruce treadmill protocol will be used to examine VO2max using a ParvoMedics TrueOne 2400 metabolic cart	8-weeks
Secondary	Muscle strength	Grip strength will be measured in a standardized way (three times in each arm) using a Jamar Dynamometer	8-weeks
Secondary	Step Count	The Fit Bit reliably measures daily steps taken, distance walked, calories burned, and overall activity level.	8-weeks
Secondary	Quality of Life (HRQOL)	The 10-item PROMIS® Global Health Scale will be used to assess key HRQOL domains including pain, fatigue, mental health, physical health, social health, and overall health	8-weeks
Secondary	Hip/Waist Circumference	Anthropometric measures	8-weeks
Secondary	Body Mass Index (BMI)	BMI will be measured according to height and weight	8-weeks
Secondary	Glucose/Lipid levels	A fasting finger stick sample of blood (35 µl) will be assessed for immediate analysis of lipid panel (i.e., total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, triglycerides) and fasting glucose	8-weeks