Clinical trial NCT00659906: Optimizing Body Composition & Health After Breast Cancer
Official title: Optimizing Body Composition & Health After Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Osteoporosis, Postmenopausal
Keywords: randomized clinical trial
cancer survivor
bone health
body composition
signs and symptoms
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2008-04-17
Enrollment: 71
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Bone mineral density (lumbar spine, proximal femur), bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links) muscle mass, fat mass.
timeFrame: 12 months
Secondary outcomes:
measure: Maximal muscle strength, leg power, gait, balance, self-report physical function and symptoms
timeFrame: 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU School of Nursing
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Kerri M Winters, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.