N/A
N=28
Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome
Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS) · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03665077 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Oxylipin Levels — 10.2; 12.1; 12.3 pg/mL — p=0.684
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Diagnostic_test)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- University of Arizona
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxylipin Levels |
10.2; 12.1; 12.3 | 0.684 |
| SECONDARY Tendon Stiffness |
5.59; 5.56 | 0.02 sig |
| SECONDARY Pain Levels |
8.0; 12.3 | 0.058 |
Summary
This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03665077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.