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

Arthritis Clinical Trial

— CIRAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890058
• Other study ID #: 2008-547
• Status: Completed
• Phase: N/A
• First received: April 27, 2009
• Last updated: August 29, 2016
• Start date: April 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2016
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Postmenopausal women aged over 18 with stage I-III breast cancer undergoing treatment at the Lombardi Cancer Center.

2. Presence of hand pain

3. No active signs of ongoing malignant disease

Exclusion Criteria:

1. Known autoimmune disease for example, rheumatoid arthritis, systemic lupus erythematosis, polymyalgia rheumatica, or seronegative arthritis.

2. Age <18

3. Unable to complete informed consent process

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthralgia
• Arthralgia Syndrome
• Arthritis
• Syndrome
• Synovitis

Locations

Country	Name	City	State
United States	Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Victoria Shanmugam

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in DAS-28 between cases and controls		1 year	No
Secondary	Differences between cases and controls in mean ESR, TNF-alpha, IL-6 and ultrasound measurement of tenosynovitis.		1 year	No