Breast Neoplasm, Osteoporosis, Postmenopausal
Conditions
Keywords
randomized clinical trial, cancer survivor, bone health, body composition, signs and symptoms
Brief summary
The purpose of this study is to conduct a 12-month randomized controlled trial comparing the effects of strength training exercise to stretching and relaxation exercise (control) on body composition (bone, muscle and fat mass), energy balance, bone turnover, and physical function (strength, power, gait, balance and self-report physical function and symptoms) in women who experienced premature menopause from chemotherapy for breast cancer.
Detailed description
As a result of treatment, breast cancer survivors typically experience unhealthy changes in body composition (bone, muscle and fat). Treatments disrupt normal bone and energy balance resulting in bone and muscle wasting and fat gain. Premenopausal women are at greatest risk for these declines because most are thrust into early menopause from chemotherapy. Hormone manipulation therapy (i.e., tamoxifen or arimidex) may further affect these tissues. Exercise can prevent bone and muscle loss and promote fat loss. However, the ability of exercise to reverse unfavorable changes in all components of body composition in women experiencing early menopause from breast cancer treatment has not been specifically studied.
Interventions
BEHAVIORALResistance Exercise
60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months
BEHAVIORALFlexibility Training
60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.
Sponsors
American Cancer Society, Inc.
OHSU Knight Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Diagnosed breast cancer stage I-IIIa * Completion of a chemotherapy regimen within the previous 5 years * Premenopausal status (9-12 menstrual cycles/year) at the initiation of chemotherapy * Complete absence of menstrual cycles for at least 6 months and within one year after starting chemotherapy OR confirmed menopause by blood tests conducted in the last 12 months prior to enrollment.
Exclusion criteria
* Presence of any known metastases * 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 planned impact activities (i.e., volleyball, basketball), or resistance training * A medical condition, disorder, or medication that contraindicates participation in moderate intensity impact or resistance exercise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density (lumbar spine, proximal femur), bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links) muscle mass, fat mass. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Maximal muscle strength, leg power, gait, balance, self-report physical function and symptoms | 12 months |
Countries
United States
Outcome results
None listed