Optimizing Body Composition & Health After Breast Cancer

NCT00659906 | Completed DMC

• 1 other identifier: 621
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm; Osteoporosis, Postmenopausal

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

1

EXPERIMENTAL

Progressive resistance training program 3 times a week for 12 months

Behavioral: Resistance Exercise

2

ACTIVE COMPARATOR

Flexibility training 3 times a week for 12 months

Behavioral: Flexibility Training

Interventions

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

1

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.

2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

OHSU School of Nursing

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• 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.

  PMID: 22996743 RESULT

• 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.

  PMID: 29141853 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis, Postmenopausal; Signs and Symptoms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kerri M Winters, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 17, 2008
• Study Start: January 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

US (1)