Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome

Study Overview
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Brief Summary
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This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.

Detailed Description
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This is a prospective single arm study enrolling patients (n = 25) with breast cancer scheduled to start adjuvant hormonal therapy. Patients would have completed all their primary treatments (surgery± radiation therapy) and are scheduled to start their adjuvant hormonal therapy. They get baseline blood drawn for oxylipins and sheer wave elastrography (SWE) ultrasound of their hands including wrists. They start adjuvant anastrozole and have blood drawn at 3mths and 6mths for measurement of oxylipins. SWE ultrasound is repeated at 6mths. This is a pilot trial to evaluate for blood and imaging biomarkers. Once pilot data is analyzed, goal is to apply for funding for a larger trial to further evaluate and validate these biomarkers

Official Title
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Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome

Conditions
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Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS), Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Initial blood draw
* Diagnostic Test: Initial SWE ultrasound
* Diagnostic Test: Blood draw at three months
* Diagnostic Test: Blood draw at six months
* Diagnostic Test: SWE ultrasound at six months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be capable of understanding the investigational nature of the study and all pertinent aspects of the study Be capable of signing and providing written consent in accordance with institutional and federal guidelines Have a histologically-confirmed diagnosis of breast cancer Be willing and able to comply with scheduled visits, treatment plan, and SWE ultrasound imaging Age ≥ 21 years Post-menopausal women with 1st event of ER+ early stage breast cancer (0-3) Completed definitive therapy (surgery ± radiation) Candidates for adjuvant AI therapy Exclusion Criteria: Have received adjuvant or neo-adjuvant chemotherapy Prior endocrine therapy (AI or tamoxifen) History of rheumatoid arthritis or other autoimmune arthritis Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use) Current use of daily corticosteroids or immunosuppressive therapies

Ages Eligible for Study
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Minimum Age: 21 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy. | Diagnostic Test: Initial blood draw<br>* At baseline, patients will undergo a blood draw.<br>Diagnostic Test: Initial SWE ultrasound<br>* At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.<br>Diagnostic Test: Blood draw at three months<br>* Blood drawn at three months to evaluate oxylipins.<br>Diagnostic Test: Blood draw at six months<br>* Blood drawn at six months to evaluate oxylipins.<br>Diagnostic Test: SWE ultrasound at six months<br>* SWE ultrasound at six months to evaluate tendon stiffness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxylipin Levels | Change Oxylipin levels at Baseline, Three and Six Months | Baseline, Three months, and Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon Stiffness | Tendon stiffness at baseline | Baseline | 
| Pain Levels | Pain levels at baseline and 6 months. Pain assessment was done using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index; the WOMAC pain assessment consists of 5 items, and each item has a scale that ranges from 0-4 (higher scores indicate higher pain levels). The scores of the 5 items are summed up to obtain the WOMAC-total pain score, which ranges from 0-20. | Baseline, Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome, AIMSS, Breast Cancer, Oxylipin