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

This study has been completed.
Sponsor:
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00890058
First received: April 27, 2009
Last updated: July 14, 2010
Last verified: April 2009
History of Changes
  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: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Case Control Study to Define Clinical, Immunologic and Radiographic Features of the Aromatase Inhibitor Arthralgia Syndrome

Resource links provided by NLM:

U.S. FDA Resources

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

Blood samples for cytokine measurements


Estimated Enrollment: 48
Study Start Date: April 2009
Study Completion Date: May 2010
Primary Completion Date: May 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:

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

Locations
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
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 by Georgetown University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Victoria Shanmugam, MD, Divsion of Rheumatology, Immunology and Allergy, Georgetown University Hospital, Washington, DC
ClinicalTrials.gov Identifier: NCT00890058     History of Changes
Other Study ID Numbers: 2008-547
Study First Received: April 27, 2009
Last Updated: July 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Arthritis
Synovitis
Aromatase Inhibitor
Arthralgia Syndrome

Additional relevant MeSH terms:
Arthralgia
Arthritis
Synovitis
Joint Diseases
Musculoskeletal Diseases
Pain
 Signs and Symptoms
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013