Clinical trial · Interventional
Optimizing Body Composition & Health After Breast Cancer
NCT00659906CI-TRIAL-00018058completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Osteoporosis, Postmenopausal | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flexibility Training | Behavioral | — | UNRESOLVED |
| Resistance Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Progressive resistance training program 3 times a week for 12 months
- interventionNames
- Behavioral: Resistance Exercise
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Flexibility training 3 times a week for 12 months
- interventionNames
- Behavioral: Flexibility Training
Primary outcomes (1)
- measure
- Bone mineral density (lumbar spine, proximal femur), bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links) muscle mass, fat mass.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (2)
- RESULTWinters-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
- DERIVEDWinters-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