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NCT02118636 · ClinicalTrials.gov registry record
Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms
A clinical trial, sponsored by Lynn Henry.
- Completed
- Registry status
- 75
- Enrollment target
NCT02118636: Completed study, sponsored by Lynn Henry.
NCT02118636 is a clinical trial that has completed, run by Lynn Henry. The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02118636 has completed, sponsored by Lynn Henry.
- COMPLETED
- Registry status
- 75 participants
- Enrollment target
Study 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.
Primary Outcome
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2009-10 |
| Est. Completion | 2015-09 |
What the finished NCT02118636 record still lists
NCT02118636 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02118636 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02118636 about?
NCT02118636 is a clinical study titled "Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms". 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 postme...
What is the current status of trial NCT02118636?
This trial is currently completed. The enrollment target is 75 participants. The study started on 2009-10. Estimated completion is 2015-09.
Who is sponsoring clinical trial NCT02118636?
This trial is sponsored by Lynn Henry, which has 4 total clinical trials registered on ClinicalTrials.gov.
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