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

• Sponsor: University of Arizona (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03665077
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

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	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome
• Actual Study Start Date: Feb 28, 2018
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Participants 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.

Outcome Measures

Primary Outcome Measures

1. Oxylipin levels [Six months]

   Compare baseline oxylipin levels in women that do vs. those that do not develop AIMSS.

2. Tendon Stiffness [Six months]

   Compare baseline tendon stiffness measured using shear wave elastography (SWE) ultrasound in women that do vs. those that do not develop AIMSS.

Secondary Outcome Measures

1. Oxylipin Correlation to Tendon Stiffness [Six months]

   Correlate changes in oxylipin panels with changes in tendon stiffness.

2. Oxylipin/Tendon Stiffness Correlation to Pain Levels [Six months]

   Correlate changes in levels of oxylipins and tendon stiffness with changes in pain scores through 6-month AI treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona Cancer Center	Tucson	Arizona	United States	85724

Sponsors and Collaborators

• University of Arizona

Investigators

• Principal Investigator: Pavani Chalasani, University of Arizona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Arizona
• ClinicalTrials.gov Identifier: NCT03665077
• Other Study ID Numbers: 1712078374; NCI-2018-00099
• First Posted: Sep 11, 2018
• Last Update Posted: Apr 15, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by University of Arizona: Aromatase Inhibitor Induced Musculoskeletal Syndrome; AIMSS; Breast Cancer; Biomarkers; Oxylipin
• Additional relevant MeSH terms: Syndrome

Study Results

No Results Posted as of Apr 15, 2022