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Completed

NCT Number: NCT00659906

Optimizing Body Composition & Health After Breast Cancer

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.

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Key information

Conditions

Breast Neoplasm Bone Diseases Bone Diseases, Metabolic Breast Diseases Breast Neoplasms Metabolic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OHSU School of Nursing

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance exercise

Behavioral

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

Flexibility Training

Behavioral

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.

Primary outcomes

  1. Bone mineral density (lumbar spine, proximal femur), bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links) muscle mass, fat mass.

    Time frame: 12 months

Secondary outcomes

  1. Maximal muscle strength, leg power, gait, balance, self-report physical function and symptoms

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 17, 2008
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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