Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients
NCT ID: NCT01051609
Last Updated: 2016-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
27 participants
OBSERVATIONAL
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Intervention Group
There is only one arm in this trial. Please see interventions for more detailed descriptions.
History and Physical Exam
The physical exam includes vital signs and ECOG performance status.
Grip Strength Measurement
A hand grip strength test will be used to measure and compare baseline and post-AI treatment forearm muscle strength in each hand.
Surveys
Self-administered surveys including Health Assessment Questionnaire Disability Index, CES-D, FACIT-F, PSQI, GAD7, number of minutes of morning stiffness, and questions pertaining to vasomotor symptoms will be used in this study to assess for presence, severity, characteristics, and associations of AI-associated musculoskeletal symptoms.
Blood Collection
A set of blood markers will be assayed at baseline, 6 months, and 12 months.
Ultrasound of Hand/Wrist
An inflammatory arthritis ultrasound scoring method similar to the RAMRIS scoring system used in rheumatoid arthritis, will evaluate joints in the most affected hand and wrist at 6 months.
Interventions
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History and Physical Exam
The physical exam includes vital signs and ECOG performance status.
Grip Strength Measurement
A hand grip strength test will be used to measure and compare baseline and post-AI treatment forearm muscle strength in each hand.
Surveys
Self-administered surveys including Health Assessment Questionnaire Disability Index, CES-D, FACIT-F, PSQI, GAD7, number of minutes of morning stiffness, and questions pertaining to vasomotor symptoms will be used in this study to assess for presence, severity, characteristics, and associations of AI-associated musculoskeletal symptoms.
Blood Collection
A set of blood markers will be assayed at baseline, 6 months, and 12 months.
Ultrasound of Hand/Wrist
An inflammatory arthritis ultrasound scoring method similar to the RAMRIS scoring system used in rheumatoid arthritis, will evaluate joints in the most affected hand and wrist at 6 months.
Eligibility Criteria
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Inclusion Criteria
* Postmenopausal, defined as at least one of the following: a) amenorrhea for at least 12 months b) prior bilateral oophorectomy at least 2 years prior to trial registration.
Exclusion Criteria
* Treatment with steroid (for any condition, except for chemotherapy premedication) within 30 days of trial registration.
* Prior treatment with an AI (patients previously or currently on tamoxifen are eligible as long as patients are off tamoxifen for 2 weeks prior to baseline blood draw)
* Active or ongoing infection
* Known metastatic disease
* Known history of HIV or hepatitis infections
* Ongoing radiation therapy (radiation must have been completed 2 weeks prior to starting treatment with an AI)
* Non-invasive (DCIS, LCIS) cancer only (no diagnosis of invasive cancer)
* Pregnant or lactating
* Unable to speak, read, and write in English
18 Years
FEMALE
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sara Hurvitz, M D
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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09-09-058
Identifier Type: -
Identifier Source: org_study_id
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