Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer, Obesity Weight Loss, Orthopedic
Therapuetic Areas:Endocrinology, Oncology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:10/19/2013
Start Date:September 2009
End Date:August 2014

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A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Third-generation Aromatase Inhibitors and Tamoxifen


Early stage hormone receptor positive breast cancer is typically treated with adjuvant
endocrine therapy in order to decrease risk of breast cancer recurrence and to improve
overall survival from the disease. Typical agents used for treatment include tamoxifen and
the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is
increasingly common because it is associated with fewer long-term serious toxicities
compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of
patients, which can influence adherence to therapy and can lead to treatment discontinuation
in a minority of cases. The mechanism underlying development of this toxicity remains
unclear, and predictors of who will develop these symptoms remain undefined. Initial reports
suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass
index may influence development of this symptom. Therefore, this longitudinal study has been
developed to determine change in grip strength over time in women treated with aromatase
inhibitors and tamoxifen, as well as to identify potential associations between change in
grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115
women with early stage breast cancer who are initiating therapy with either an aromatase
inhibitor or tamoxifen will be enrolled.


Inclusion Criteria:

- Stage 0-III breast cancer who are scheduled to receive endocrine therapy with
tamoxifen or an aromatase inhibitor

- All prior surgery and chemotherapy should be complete

- Age 18 and above and postmenopausal

Exclusion Criteria:

- Major rheumatologic disorders

- Concomitant sex hormone containing drugs or Leutinizing Hormone Releasing Hormone
agonist therapy

- For those subjects initiating treatment with an aromatase inhibitor, prior tamoxifen
within 4 weeks of enrollment

- For those subjects initiating treatment with tamoxifen, prior aromatase inhibitor
within 4 weeks of enrollment
We found this trial at
1
site
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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