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

Primary Purpose

Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS), Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Initial blood draw
Initial SWE ultrasound
Blood draw at three months
Blood draw at six months
SWE ultrasound at six months
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS) focused on measuring Aromatase Inhibitor Induced Musculoskeletal Syndrome, AIMSS, Breast Cancer, Biomarkers, Oxylipin

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arizona Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.

Outcomes

Primary Outcome Measures

Oxylipin Levels
Change Oxylipin levels at Baseline, Three and Six Months

Secondary Outcome Measures

Tendon Stiffness
Tendon stiffness at baseline
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.

Full Information

First Posted
September 7, 2018
Last Updated
August 10, 2023
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT03665077
Brief Title
Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome
Official Title
Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS), Breast Cancer
Keywords
Aromatase Inhibitor Induced Musculoskeletal Syndrome, AIMSS, Breast Cancer, Biomarkers, Oxylipin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Arm Description
Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.
Intervention Type
Diagnostic Test
Intervention Name(s)
Initial blood draw
Intervention Description
At baseline, patients will undergo a blood draw.
Intervention Type
Diagnostic Test
Intervention Name(s)
Initial SWE ultrasound
Intervention Description
At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood draw at three months
Intervention Description
Blood drawn at three months to evaluate oxylipins.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood draw at six months
Intervention Description
Blood drawn at six months to evaluate oxylipins.
Intervention Type
Diagnostic Test
Intervention Name(s)
SWE ultrasound at six months
Intervention Description
SWE ultrasound at six months to evaluate tendon stiffness.
Primary Outcome Measure Information:
Title
Oxylipin Levels
Description
Change Oxylipin levels at Baseline, Three and Six Months
Time Frame
Baseline, Three months, and Six months
Secondary Outcome Measure Information:
Title
Tendon Stiffness
Description
Tendon stiffness at baseline
Time Frame
Baseline
Title
Pain Levels
Description
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.
Time Frame
Baseline, Six months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Post-menopausal women
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavani Chalasani
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/36984892/
Description
Oxylipins as Biomarkers for Aromatase Inhibitor-Induced Arthralgia (AIA) in Breast Cancer Patients
URL
https://pubmed.ncbi.nlm.nih.gov/35207339/
Description
Feasibility Trial to Evaluate Tendon Stiffness Obtained from Shear Wave Elastography Imaging as a Biomarker of Aromatase Inhibitor-Induced Arthralgias

Learn more about this trial

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

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