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

University of Arizona28 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS)Breast Cancer

Interventions

Initial blood drawDIAGNOSTIC_TEST

At baseline, patients will undergo a blood draw.

Initial SWE ultrasoundDIAGNOSTIC_TEST

At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.

Blood draw at three monthsDIAGNOSTIC_TEST

Blood drawn at three months to evaluate oxylipins.

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be capable of understanding the investigational nature of the study and all pertinent aspects of the study 2. Be capable of signing and providing written consent in accordance with institutional and federal guidelines 3. Have a histologically-confirmed diagnosis of breast cancer 4. Be willing and able to comply with scheduled visits, treatment plan, and SWE ultrasound imaging 5. Age ≥ 21 years 6. Post-menopausal women with 1st event of ER+ early stage breast cancer (0-3) 7. Completed definitive therapy (surgery ± radiation) 8. Candidates for adjuvant AI therapy Exclusion Criteria: 1. Have received adjuvant or neo-adjuvant chemotherapy 2. Prior endocrine therapy (AI or tamoxifen) 3. History of rheumatoid arthritis or other autoimmune arthritis 4. Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use) 5. Current use of daily corticosteroids or immunosuppressive therapies

Locations (1)

University of Arizona Cancer Center

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Oxylipin Levels

Change Oxylipin levels at Baseline, Three and Six Months

Time frame: Baseline, Three months, and Six months

Secondary Outcomes

Tendon Stiffness

Tendon stiffness at baseline

Time frame: 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.

Time frame: Baseline, Six months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.