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Optimizing Body Composition & Health After Breast Cancer

Not Enrolling
Breast Neoplasm, Osteoporosis, Postmenopausal

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Trial Information

Optimizing Body Composition & Health After Breast Cancer

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Kerri M Winters, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University


United States: Institutional Review Board

Study ID:




Start Date:

January 2006

Completion Date:

January 2009

Related Keywords:

  • Breast Neoplasm
  • Osteoporosis, Postmenopausal
  • randomized clinical trial
  • cancer survivor
  • bone health
  • body composition
  • signs and symptoms
  • Breast Neoplasms
  • Neoplasms
  • Osteoporosis
  • Osteoporosis, Postmenopausal



OHSU School of NursingPortland, Oregon  97239