Optimizing Body Composition & Health After Breast Cancer

Not Applicable

Completed

• Conditions: Breast Neoplasm; Osteoporosis, Postmenopausal
• Interventions: Behavioral: Flexibility Training; Behavioral: Resistance Exercise

• Registration Number: NCT00659906
• Lead Sponsor: OHSU Knight Cancer Institute

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-04-11
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-17
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Flexibility Training	Flexibility training 3 times a week for 12 months
1	Resistance Exercise	Progressive resistance training program 3 times a week for 12 months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Maximal muscle strength, leg power, gait, balance, self-report physical function and symptoms	12 months

Trial Locations

Locations (1)

OHSU School of Nursing; 🇺🇸 Portland, Oregon, United States