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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665077
• Other study ID #: 1712078374
• Secondary ID: NCI-2018-00099
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: June 15, 2022

Study information

• Verified date: August 2023
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS)
• Breast Cancer
• Syndrome

Intervention

Diagnostic Test:
• Initial blood draw
At baseline, patients will undergo a blood draw.
• Initial SWE ultrasound
At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.
• Blood draw at three months
Blood drawn at three months to evaluate oxylipins.
• Blood draw at six months
Blood drawn at six months to evaluate oxylipins.
• SWE ultrasound at six months
SWE ultrasound at six months to evaluate tendon stiffness.

Locations

Country	Name	City	State
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxylipin Levels	Change Oxylipin levels at Baseline, Three and Six Months	Baseline, Three months, and Six months
Secondary	Tendon Stiffness	Tendon stiffness at baseline	Baseline
Secondary	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

External Links

•   Feasibility Trial to Evaluate Tendon Stiffness Obtained from Shear Wave Elastography Imaging as a Biomarker of Aromatase Inhibitor-Induced Arthralgias
•   Oxylipins as Biomarkers for Aromatase Inhibitor-Induced Arthralgia (AIA) in Breast Cancer Patients