Working… Menu

Optimizing Body Composition & Health After Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00659906
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : May 28, 2015
American Cancer Society, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Osteoporosis, Postmenopausal Behavioral: Resistance Exercise Behavioral: Flexibility Training Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Optimizing Body Composition & Health After Breast Cancer
Study Start Date : January 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 1
Progressive resistance training program 3 times a week for 12 months
Behavioral: Resistance 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

Active Comparator: 2
Flexibility training 3 times a week for 12 months
Behavioral: Flexibility 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.

Primary Outcome Measures :
  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 Outcome Measures :
  1. Maximal muscle strength, leg power, gait, balance, self-report physical function and symptoms [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00659906

Layout table for location information
United States, Oregon
OHSU School of Nursing
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
American Cancer Society, Inc.
Layout table for investigator information
Principal Investigator: Kerri M Winters, PhD Oregon Health and Science University

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: OHSU Knight Cancer Institute Identifier: NCT00659906     History of Changes
Other Study ID Numbers: 621
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by OHSU Knight Cancer Institute:
randomized clinical trial
cancer survivor
bone health
body composition
signs and symptoms
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases