Clinical trial NCT02248350: An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Official title: An Exercise Intervention to Mitigate Side-Effects Related to Androgen Deprivation Therapy Among Prostate Cancer Survivors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Physical Activity
Side-effects
Keywords: prostate cancer
physical activity
exercise
intervention
side effects
androgen deprivation therapy
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2014-09-25
Enrollment: 19
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Bone Mineral Density
timeFrame: 8-weeks
Secondary outcomes:
measure: Physical Fitness
timeFrame: 8-weeks
measure: Muscle strength
timeFrame: 8-weeks
measure: Step Count
timeFrame: 8-weeks
measure: Quality of Life (HRQOL)
timeFrame: 8-weeks
measure: Hip/Waist Circumference
timeFrame: 8-weeks
measure: Body Mass Index (BMI)
timeFrame: 8-weeks
measure: Glucose/Lipid levels
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Office of Minority Health and Health Disparities Research
state: District of Columbia
Study officials:
References: