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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Arthralgia Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AI therapy

Subjects who started treatment with any of the three aromatase inhibitor (AI) medications

anastrozole, letrozole, exemestane

Intervention Type DRUG

Patients were treated with one of the listed anti-hormonal medications for up to one year

Tamoxifen

Subjects who started treatment with tamoxifen

Tamoxifen

Intervention Type DRUG

Patients were treated with tamoxifen for up to one year

Interventions

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anastrozole, letrozole, exemestane

Patients were treated with one of the listed anti-hormonal medications for up to one year

Intervention Type DRUG

Tamoxifen

Patients were treated with tamoxifen for up to one year

Intervention Type DRUG

Other Intervention Names

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Arimidex, Femara, Aromasin Novaldex

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No