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An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy (MIGHTY)

Primary Purpose

Prostate Cancer, Physical Activity, Side-effects

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supervised and Home Based Exercise
Stretching Control Group
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring prostate cancer, physical activity, exercise, intervention, side effects, androgen deprivation therapy

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Office of Minority Health and Health Disparities Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Group

Stretching Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Bone Mineral Density
BMD will be measured by a DXA scan

Secondary Outcome Measures

Physical Fitness
. The Bruce treadmill protocol will be used to examine VO2max using a ParvoMedics TrueOne 2400 metabolic cart
Muscle strength
Grip strength will be measured in a standardized way (three times in each arm) using a Jamar Dynamometer
Step Count
The Fit Bit reliably measures daily steps taken, distance walked, calories burned, and overall activity level.
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
Hip/Waist Circumference
Anthropometric measures
Body Mass Index (BMI)
BMI will be measured according to height and weight
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

Full Information

First Posted
September 22, 2014
Last Updated
February 13, 2018
Sponsor
Georgetown University
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02248350
Brief Title
An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Acronym
MIGHTY
Official Title
An Exercise Intervention to Mitigate Side-Effects Related to Androgen Deprivation Therapy Among Prostate Cancer Survivors.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Physical Activity, Side-effects
Keywords
prostate cancer, physical activity, exercise, intervention, side effects, androgen deprivation therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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
Arm Title
Stretching Control group
Arm Type
Active Comparator
Arm Description
Informational booklet containing stretching exercises (20-minutes a day)
Intervention Type
Behavioral
Intervention Name(s)
Supervised and Home Based Exercise
Intervention Description
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
Intervention Name(s)
Stretching Control Group
Intervention Description
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 Outcome Measure Information:
Title
Bone Mineral Density
Description
BMD will be measured by a DXA scan
Time Frame
8-weeks
Secondary Outcome Measure Information:
Title
Physical Fitness
Description
. The Bruce treadmill protocol will be used to examine VO2max using a ParvoMedics TrueOne 2400 metabolic cart
Time Frame
8-weeks
Title
Muscle strength
Description
Grip strength will be measured in a standardized way (three times in each arm) using a Jamar Dynamometer
Time Frame
8-weeks
Title
Step Count
Description
The Fit Bit reliably measures daily steps taken, distance walked, calories burned, and overall activity level.
Time Frame
8-weeks
Title
Quality of Life (HRQOL)
Description
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
Time Frame
8-weeks
Title
Hip/Waist Circumference
Description
Anthropometric measures
Time Frame
8-weeks
Title
Body Mass Index (BMI)
Description
BMI will be measured according to height and weight
Time Frame
8-weeks
Title
Glucose/Lipid levels
Description
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
Time Frame
8-weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Office of Minority Health and Health Disparities Research
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States

12. IPD Sharing Statement

Learn more about this trial

An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy

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