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Completed

NCT Number: NCT03665077

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

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

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Initial blood draw

Diagnostic Test

At baseline, patients will undergo a blood draw.

Initial SWE ultrasound

Diagnostic Test

At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.

Blood draw at three months

Diagnostic Test

Blood drawn at three months to evaluate oxylipins.

Blood draw at six months

Diagnostic Test

Blood drawn at six months to evaluate oxylipins.

SWE ultrasound at six months

Diagnostic Test

SWE ultrasound at six months to evaluate tendon stiffness.

Primary outcomes

  1. Oxylipin Levels

    Time frame: Baseline, Three months, and Six months

    Change Oxylipin levels at Baseline, Three and Six Months

Secondary outcomes

  1. Tendon Stiffness

    Time frame: Baseline

    Tendon stiffness at baseline

  2. Pain Levels

    Time frame: Baseline, Six months

    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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 11, 2018
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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