A Case Control Study to Define Clinical, Immunologic and Radiographic Features of the Aromatase Inhibitor Arthralgia Syndrome (CIRAS)
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|ClinicalTrials.gov Identifier: NCT00890058|
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : August 30, 2016
|Condition or disease|
|Arthralgia Syndrome Arthritis Synovitis|
This study is for women with post-menopausal breast cancer and hand pain. Patients do not need to be taking aromatase inhibitors to be eligible for the study. We want to study the joint findings in patients with hand pain and breast cancer undergoing treatment with aromatase inhibitor medications and compare them to patients with hand pain and breast cancer not treated with these medications.
Aromatase inhibitor drugs are used in certain types of breast cancer to reduce the risk of cancer returning after treatment. One of the side effects of aromatase inhibitors is the development of joint pain, a complication known as the Arthralgia Syndrome. The cause of the Arthralgia Syndrome is not known, but we suspect that the pain may be due to inflammation in the joints. Currently, the only effective treatment is to stop the aromatase inhibitor, and so affected patients may miss out on an otherwise useful treatment to prevent return of their cancer.
Post-menopausal patients with breast cancer and hand pain can enroll in the study. Patients will be asked to come for a separate visit which will take about half a day.
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|Observational Model:||Case Control|
|Official Title:||A Case Control Study to Define Clinical, Immunologic and Radiographic Features of the Aromatase Inhibitor Arthralgia Syndrome|
|Study Start Date :||April 2009|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
Postmenopausal breast cancer patients with hand pain receiving aromatase inhibitors
Postmenopausal breast cancer patients with hand pain not receiving aromatase inhibitors
- Difference in DAS-28 between cases and controls [ Time Frame: 1 year ]
- Differences between cases and controls in mean ESR, TNF-alpha, IL-6 and ultrasound measurement of tenosynovitis. [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA
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): NCT00890058
|United States, District of Columbia|
|Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Victoria Shanmugam, MD||Georgetown University Hospital|