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

Study Overview
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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.

Official Title
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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

Conditions
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Breast Cancer, Arthralgia, Obesity

Intervention / Treatment
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* Drug: anastrozole, letrozole, exemestane
* Drug: Tamoxifen


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AI therapy<br>Subjects who started treatment with any of the three aromatase inhibitor (AI) medications | Drug: anastrozole, letrozole, exemestane<br>* Patients were treated with one of the listed anti-hormonal medications for up to one year<br>* Other names: Arimidex, Femara, Aromasin;|
| Tamoxifen<br>Subjects who started treatment with tamoxifen | Drug: Tamoxifen<br>* Patients were treated with tamoxifen for up to one year<br>* Other names: Novaldex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy | Change in BMI between baseline and 12 months of endocrine therapy | baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Medication on Change in Grip Strength | Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months | baseline and 12 months | 
| Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months | Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment | baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Joint pain, Grip strength, Hormone receptor positive breast cancer