Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01051609|
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : September 9, 2016
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: History and Physical Exam Other: Grip Strength Measurement Behavioral: Surveys Other: Blood Collection Procedure: Ultrasound of Hand/Wrist|
|Study Type :||Observational|
|Actual Enrollment :||27 participants|
|Official Title:||Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||July 2013|
There is only one arm in this trial. Please see interventions for more detailed descriptions.
Other: History and Physical Exam
The physical exam includes vital signs and ECOG performance status.
Other: 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.
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.
Other: Blood Collection
A set of blood markers will be assayed at baseline, 6 months, and 12 months.
Procedure: 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.
- Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score. [ Time Frame: Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor ]
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): NCT01051609
|United States, California|
|UCLA Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Sara Hurvitz, M D||University of California, Los Angeles|