Optimizing Body Composition & Health After Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimizing Body Composition & Health After Breast Cancer

Conditions
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Breast Neoplasm, Osteoporosis, Postmenopausal

Intervention / Treatment
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* Behavioral: Resistance Exercise
* Behavioral: Flexibility Training


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Progressive resistance training program 3 times a week for 12 months | Behavioral: Resistance Exercise<br>* 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<br>|
| Active Comparator: 2<br>Flexibility training 3 times a week for 12 months | Behavioral: Flexibility Training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal muscle strength, leg power, gait, balance, self-report physical function and symptoms |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized clinical trial, cancer survivor, bone health, body composition, signs and symptoms