University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
NCT Number: NCT03665077
This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.
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Notify Me21 year and older
Female
Interventional
Not applicable
Tucson, Arizona, 85724, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At baseline, patients will undergo a blood draw.
At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.
Blood drawn at three months to evaluate oxylipins.
Blood drawn at six months to evaluate oxylipins.
SWE ultrasound at six months to evaluate tendon stiffness.
Time frame: Baseline, Three months, and Six months
Change Oxylipin levels at Baseline, Three and Six Months
Time frame: Baseline
Tendon stiffness at baseline
Time frame: Baseline, Six months
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.
University of Arizona
Other
Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome
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