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

August 29, 2016 updated by: Victoria Shanmugam
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Cases
Postmenopausal breast cancer patients with hand pain receiving aromatase inhibitors
Controls
Postmenopausal breast cancer patients with hand pain not receiving aromatase inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in DAS-28 between cases and controls
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences between cases and controls in mean ESR, TNF-alpha, IL-6 and ultrasound measurement of tenosynovitis.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Victoria Shanmugam

Investigators

  • Principal Investigator: Victoria Shanmugam, MD, Georgetown University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 28, 2009

First Posted (Estimate)

April 29, 2009

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-547

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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