A Case Control Study to Define Clinical, Immunologic and Radiographic Features of the Aromatase Inhibitor Arthralgia Syndrome - Full Text View

Sponsor:	Georgetown University
Information provided by:	Georgetown University
ClinicalTrials.gov Identifier:	NCT00890058

Purpose

The CIRAS study will investigate postmenopausal breast cancer patients with hand pain and compare those receiving aromatase inhibitors (cases) to breast cancer patients with hand pain not receiving aromatase inhibitors (controls) in order assess whether this syndrome is an inflammatory arthritis.

Condition
Arthralgia Syndrome Arthritis Synovitis

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	A Case Control Study to Define Clinical, Immunologic and Radiographic Features of the Aromatase Inhibitor Arthralgia Syndrome

Further study details as provided by Georgetown University:

Primary Outcome Measures:

Difference in DAS-28 between cases and controls [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Differences between cases and controls in mean ESR, TNF-alpha, IL-6 and ultrasound measurement of tenosynovitis. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Blood samples for cytokine measurements

Estimated Enrollment:	48
Study Start Date:	April 2009
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cases Postmenopausal breast cancer patients with hand pain receiving aromatase inhibitors
Controls Postmenopausal breast cancer patients with hand pain not receiving aromatase inhibitors

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Postmenopausal women with stage I-III breast cancer currently undergoing treatment at the Lombardi Cancer Center will be screened for the presence of joint and hand symptoms.Patients with symptoms who are receiving aromatase inhibitors will be considered to be cases, while those with symptoms who are not receiving aromatase inhibitors will be considered to be controls.

Criteria

Inclusion Criteria:

Postmenopausal women aged over 18 with stage I-III breast cancer undergoing treatment at the Lombardi Cancer Center.
Presence of hand pain
No active signs of ongoing malignant disease

Exclusion Criteria:

Known autoimmune disease for example, rheumatoid arthritis, systemic lupus erythematosis, polymyalgia rheumatica, or seronegative arthritis.
Age <18
Unable to complete informed consent process

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890058

Locations

United States, District of Columbia
Georgetown University Hospital	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Victoria K Shanmugam, MD 202-444-6200 vks4@gunet.georgetown.edu
Contact: Jennifer Lemoine, PhD 202-687-8682 jl583@georgetown.edu
Principal Investigator: Victoria K Shanmugam, MD
Sub-Investigator: Jennifer Eng-Wong, MD
Sub-Investigator: Jennifer Lemoine, PhD

Sponsors and Collaborators

Georgetown University

Investigators

Principal Investigator:

Victoria Shanmugam, MD

Georgetown University Hospital

More Information

Additional Information:

Lombardi Cancer Center Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Divsion of Rheumatology, Immunology and Allergy, Georgetown University Hospital, Washington, DC ( Victoria Shanmugam, MD )
Study ID Numbers:	2008-547
Study First Received:	April 27, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00890058 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Georgetown University:

Arthritis
Synovitis
Aromatase Inhibitor
Arthralgia Syndrome

Additional relevant MeSH terms:

Disease
Molecular Mechanisms of Pharmacological Action
Joint Diseases
Pain
Enzyme Inhibitors
Pharmacologic Actions
Signs and Symptoms

Pathologic Processes
Musculoskeletal Diseases
Arthritis
Syndrome
Synovitis
Aromatase Inhibitors
Arthralgia

ClinicalTrials.gov processed this record on February 08, 2010