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Optimizing Body Composition & Health After Breast Cancer

Primary Purpose

Breast Neoplasm, Osteoporosis, Postmenopausal

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Resistance Exercise

Flexibility Training

About this trial

This is an interventional supportive care trial for Breast Neoplasm focused on measuring randomized clinical trial, cancer survivor, bone health, body composition, signs and symptoms

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

OHSU School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Progressive resistance training program 3 times a week for 12 months

Flexibility training 3 times a week for 12 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00659906

First Posted

April 11, 2008

Last Updated

May 26, 2015

Sponsor

OHSU Knight Cancer Institute

Collaborators

American Cancer Society, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00659906

Brief Title

Optimizing Body Composition & Health After Breast Cancer

Official Title

Optimizing Body Composition & Health After Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

OHSU Knight Cancer Institute

Collaborators

American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasm, Osteoporosis, Postmenopausal

Keywords

randomized clinical trial, cancer survivor, bone health, body composition, signs and symptoms

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Progressive resistance training program 3 times a week for 12 months

Arm Title

Arm Type

Active Comparator

Arm Description

Flexibility training 3 times a week for 12 months

Intervention Type

Behavioral

Intervention Name(s)

Resistance Exercise

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Flexibility Training

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

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

Time Frame

12 months

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kerri M Winters, PhD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

Facility Information:

Facility Name

OHSU School of Nursing

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22996743

Citation

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. Osteoporos Int. 2013 May;24(5):1637-46. doi: 10.1007/s00198-012-2143-2. Epub 2012 Sep 21.

Results Reference

result

PubMed Identifier

29141853

Citation

Winters-Stone KM, Wood LJ, Stoyles S, Dieckmann NF. The Effects of Resistance Exercise on Biomarkers of Breast Cancer Prognosis: A Pooled Analysis of Three Randomized Trials. Cancer Epidemiol Biomarkers Prev. 2018 Feb;27(2):146-153. doi: 10.1158/1055-9965.EPI-17-0766. Epub 2017 Nov 15.

Results Reference

derived

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Optimizing Body Composition & Health After Breast Cancer

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