Optimizing Body Composition & Health After Breast Cancer

Breast Neoplasm Clinical Trial

Official title:

Optimizing Body Composition & Health After Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659906
• Other study ID #: 621
• Status: Completed
• Phase: N/A
• First received: April 11, 2008
• Last updated: May 26, 2015
• Start date: January 2006
• Est. completion date: January 2009

Study information

• Verified date: May 2015
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Osteoporosis, Postmenopausal

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	OHSU School of Nursing	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Winters-Stone KM, Dobek J, Nail LM, Bennett JA, Leo MC, Torgrimson-Ojerio B, Luoh SW, Schwartz A. Impact + resistance training improves bone health and body composition in prematurely menopausal breast cancer survivors: a randomized controlled trial. Oste — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density (lumbar spine, proximal femur), bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links) muscle mass, fat mass.		12 months	No
Secondary	Maximal muscle strength, leg power, gait, balance, self-report physical function and symptoms		12 months	No