Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms

Completed

• Conditions: Breast Cancer; Arthralgia

• Registration Number: NCT02118636
• Lead Sponsor: Lynn Henry

Brief Summary

Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. This observational study is designed to collect patient-reported outcomes and serial serum samples in order to investigate potential etiologies of this bothersome toxicity.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2013-09
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Study Completion: 2015-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• Stage I-III breast cancer who are scheduled to receive endocrine therapy with an aromatase inhibitor
• All prior surgery, chemotherapy, and radiation therapy should be complete or should be completed by the time of AI treatment initiation (within 28 days of study enrollment)
• Age 21 and above and postmenopausal

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in estradiol and development of musculoskeletal symptoms between baseline and 3 months	12 months	To identify associations between estradiol serum concentrations at baseline and after 3 months of aromatase inhibitor therapy and the development of aromatase inhibitor-associated musculoskeletal symptoms by 12 months

Secondary Outcome Measures

Name	Time	Method
Change in sex hormones and development of musculoskeletal symptoms between baseline and 3 months	12 months	To identify associations between change in estrogens and androgens at baseline and 3 months of aromatase inhibitor therapy and development of aromatase inhibitor-associated musculoskeletal symptoms by 12 months

Trial Locations

Locations (1)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States