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NCT01983995 · ClinicalTrials.gov registry record
Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated Patients
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 49
- Enrollment target
NCT01983995: Completed study, sponsored by University of Michigan.
NCT01983995 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 49 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01983995 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 49 participants
- Enrollment target
Study Summary
Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with breast cancer. These medications can cause side effects in some women, and occasionally they can be quite bothersome. We are doing a study to better understand the side effects of aromatase inhibitors so that we can hopefully treat them better or possibly prevent them. In particular, we are interested in pain and difficulty sleeping. This study is designed to assess the effect of aromatase inhibitors on pain, sleep quality, and fatigue and the interplay of these side effects and their subsequent impact on daily activity. Each participant will fill out a series of questionnaires about pain, sleep quality, and fatigue and will also complete a sleep diary and wear an actigraphy watch for 10 days before starting an aromatase inhibitor and after taking it for 3 months. We hope to learn more about these symptoms so we can better manage medication toxicity in the future.
Primary Outcome
Feasibility will be measured by the proportion of breast cancer patients who are starting aromatase inhibitor therapy who complete baseline and 3 month assessment questionnaires and also enter actigraphy data correctly at least 85% of the time.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-09 |
What the finished NCT01983995 record still lists
NCT01983995 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 49 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01983995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01983995 about?
NCT01983995 is a clinical study titled "Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated Patients". Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with breast cancer. These medications can cause side effects in some women, and occasionally they can be quite bothersome. We are doing a study to better understand the side effects of aromatase inhibitors so that we ...
What is the current status of trial NCT01983995?
This trial is currently completed. The enrollment target is 49 participants. The study started on 2013-11. Estimated completion is 2016-09.
Who is sponsoring clinical trial NCT01983995?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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