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NCT Number: NCT02248350

An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy

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.

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Key information

Conditions

Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Physical Activity Prostatic Diseases Prostatic Neoplasms Side-effects Urogenital Diseases Urogenital Neoplasms

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Office of Minority Health and Health Disparities Research

Washington D.C., District of Columbia, 20003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised and Home Based Exercise

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

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.

Primary outcomes

  1. Bone Mineral Density

    Time frame: 8-weeks

    BMD will be measured by a DXA scan

Secondary outcomes

  1. Physical Fitness

    Time frame: 8-weeks

    . The Bruce treadmill protocol will be used to examine VO2max using a ParvoMedics TrueOne 2400 metabolic cart

  2. Muscle strength

    Time frame: 8-weeks

    Grip strength will be measured in a standardized way (three times in each arm) using a Jamar Dynamometer

  3. Step Count

    Time frame: 8-weeks

    The Fit Bit reliably measures daily steps taken, distance walked, calories burned, and overall activity level.

  4. Quality of Life (HRQOL)

    Time frame: 8-weeks

    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

  5. Hip/Waist Circumference

    Time frame: 8-weeks

    Anthropometric measures

  6. Body Mass Index (BMI)

    Time frame: 8-weeks

    BMI will be measured according to height and weight

  7. Glucose/Lipid levels

    Time frame: 8-weeks

    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

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

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

Acronym: MIGHTY

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2014
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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