Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome
|ClinicalTrials.gov Identifier: NCT03665077|
Recruitment Status : Suspended (per IRB)
First Posted : September 11, 2018
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS) Breast Cancer||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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome|
|Actual Study Start Date :||February 28, 2018|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||March 1, 2022|
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
At baseline, patients will undergo a blood draw.
Diagnostic Test: Initial SWE ultrasound
At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.
Diagnostic Test: Blood draw at three months
Blood drawn at three months to evaluate oxylipins.
Diagnostic Test: Blood draw at six months
Blood drawn at six months to evaluate oxylipins.
Diagnostic Test: SWE ultrasound at six months
SWE ultrasound at six months to evaluate tendon stiffness.
- Oxylipin levels [ Time Frame: Six months ]Compare baseline oxylipin levels in women that do vs. those that do not develop AIMSS.
- Tendon Stiffness [ Time Frame: Six months ]Compare baseline tendon stiffness measured using shear wave elastography (SWE) ultrasound in women that do vs. those that do not develop AIMSS.
- Oxylipin Correlation to Tendon Stiffness [ Time Frame: Six months ]Correlate changes in oxylipin panels with changes in tendon stiffness.
- Oxylipin/Tendon Stiffness Correlation to Pain Levels [ Time Frame: Six months ]Correlate changes in levels of oxylipins and tendon stiffness with changes in pain scores through 6-month AI treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665077
|United States, Arizona|
|University of Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Pavani Chalasani||University of Arizona|