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

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ClinicalTrials.gov Identifier: NCT03665077
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arizona

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
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

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

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Oxylipin levels [ Time Frame: Six months ]
    Compare baseline oxylipin levels in women that do vs. those that do not develop AIMSS.

  2. Tendon Stiffness [ Time Frame: 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 [ Time Frame: Six months ]
    Correlate changes in oxylipin panels with changes in tendon stiffness.

  2. Oxylipin/Tendon Stiffness Correlation to Pain Levels [ Time Frame: Six months ]
    Correlate changes in levels of oxylipins and tendon stiffness with changes in pain scores through 6-month AI treatment.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Post-menopausal women
Sampling Method:   Non-Probability Sample
Study Population
Patients 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665077


Contacts
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Contact: Pavani Chalasani, MD (520) 694-2873 pchalasani@uacc.arizona.edu
Contact: Dana Lewallen (520) 626-2175 dlewallen@uacc.arizona.edu

Locations
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United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Amy Selegue, BA, BSN, RN    520-626-0301    aselegue@email.arizona.edu   
Principal Investigator: Pavani Chalasani, MD         
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Pavani Chalasani University of Arizona

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03665077     History of Changes
Other Study ID Numbers: 1712078374
NCI-2018-00099 ( Registry Identifier: NCI Trial Identifier )
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Arizona:
Aromatase Inhibitor Induced Musculoskeletal Syndrome
AIMSS
Breast Cancer
Biomarkers
Oxylipin

Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs