Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare pre and post Aromatase Inhibitor (AI) treatment serological markers of inflammation and assess for correlation with AI-MS.

Official Title
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Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: History and Physical Exam
* Other: Grip Strength Measurement
* Behavioral: Surveys
* Other: Blood Collection
* Procedure: Ultrasound of Hand/Wrist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years and older with non-metastatic hormone receptor (ER and/or PR) positive breast cancer who are eligible for and planning on starting treatment with an AI within one month of signing consent. Postmenopausal, defined as at least one of the following: a) amenorrhea for at least 12 months b) prior bilateral oophorectomy at least 2 years prior to trial registration. Exclusion Criteria: History of autoimmune connective tissue disease, such as rheumatoid arthritis, lupus, or other autoimmune conditions affecting joints. Treatment with steroid (for any condition, except for chemotherapy premedication) within 30 days of trial registration. Prior treatment with an AI (patients previously or currently on tamoxifen are eligible as long as patients are off tamoxifen for 2 weeks prior to baseline blood draw) Active or ongoing infection Known metastatic disease Known history of HIV or hepatitis infections Ongoing radiation therapy (radiation must have been completed 2 weeks prior to starting treatment with an AI) Non-invasive (DCIS, LCIS) cancer only (no diagnosis of invasive cancer) Pregnant or lactating Unable to speak, read, and write in English

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 |
| --- | --- |
| Intervention Group<br>There is only one arm in this trial. Please see interventions for more detailed descriptions. | Other: History and Physical Exam<br>* The physical exam includes vital signs and ECOG performance status.<br>Other: Grip Strength Measurement<br>* A hand grip strength test will be used to measure and compare baseline and post-AI treatment forearm muscle strength in each hand.<br>Behavioral: Surveys<br>* Self-administered surveys including Health Assessment Questionnaire Disability Index, CES-D, FACIT-F, PSQI, GAD7, number of minutes of morning stiffness, and questions pertaining to vasomotor symptoms will be used in this study to assess for presence, severity, characteristics, and associations of AI-associated musculoskeletal symptoms.<br>Other: Blood Collection<br>* A set of blood markers will be assayed at baseline, 6 months, and 12 months.<br>Procedure: Ultrasound of Hand/Wrist<br>* An inflammatory arthritis ultrasound scoring method similar to the RAMRIS scoring system used in rheumatoid arthritis, will evaluate joints in the most affected hand and wrist at 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score. |  | Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Menopausal, Breast Cancer