Clinical trial NCT00660686: Exercise for Physical Health in Men With Prostate Cancer
Official title: Exercise for Physical Health in Men With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasm
Osteoporosis
Keywords: randomized clinical trial
elderly
cancer survivor
bone health
body composition
signs and symptoms
Androgen Deprivation Therapy
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Lance Armstrong Foundation
First posted: 2008-04-17
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to conduct a 12-month randomized controlled trial comparing the effects of strength and impact exercise training to flexibility/relaxation training on body composition (bone, muscle and fat mass), physical function (strength, gait, power, balance and self-report physical function and symptoms) in men currently treated with hormone therapy for prostate cancer.

Detailed description: Prostate cancer survivors with advanced disease are commonly treated with androgen deprivation therapy (ADT) to reduce testosterone. Serious side effects of ADT are rapid bone and muscle loss that can lead to osteoporosis and declines in neuromuscular function (strength, power, gait and balance) which increases the risk of fracture and falls (a risk factor for fracture) and impairs physical function. Men on ADT are 1.4 times more likely to fracture compared with their cancer-free peers and those who fracture have a poorer prognosis than those who do not. Self-report physical function is also lower among men on ADT. Exercise can prevent bone loss, neuromuscular declines and falls in several populations. However, the ability of exercise to prevent bone loss from ADT has not been tested, while data on exercise and neuromuscular function (strength only) in this population are limited to one published trial. The long-term goal of our research is to improve musculoskeletal health and function in cancer survivors. Critical first steps to meet this goal are to determine whether our previously tested program of impact and resistance exercise, shown to improve bone health and neuromuscular function in women, can prevent bone loss and neuromuscular declines in prostate cancer survivors on ADT. Based on our previous research, we have developed the Prevent Osteoporosis With Impact + Resistance (POWIR) program to be adapted to clinical populations at risk for bone loss and declines in neuromuscular function. Potentially, POWIR could mitigate bone and muscle losses from ADT, and thereby lower fracture risk and improve quality of life.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed prostate cancer
* presently receiving or planning to begin androgen deprivation therapy for prostate cancer

Exclusion Criteria:

* Presence of bone metastases in the proximal femur and lumbar spine
* Clinically defined osteoporosis
* Current or previous use of medications known to affect bone metabolism
* Current regular participation (\>2x/wk for at least 30 min/session) in a planned session of moderate-vigorous impact or resistance training
* A medical condition, disorder, or medication that contraindicates participation in moderate intensity impact or resistance exercise

Primary outcomes:
measure: bone mineral density, bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links), muscle mass, fat mass.
timeFrame: 12 months
Secondary outcomes:
measure: maximal muscle strength, gait, balance, self-report physical function, symptoms
timeFrame: 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU School of Nursing
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Kerri M Winters, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winters-Stone KM, Dobek JC, Bennett JA, Dieckmann NF, Maddalozzo GF, Ryan CW, Beer TM. Resistance training reduces disability in prostate cancer survivors on androgen deprivation therapy: evidence from a randomized controlled trial. Arch Phys Med Rehabil. 2015 Jan;96(1):7-14. doi: 10.1016/j.apmr.2014.08.010. Epub 2014 Sep 3.