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NCT01912612 · ClinicalTrials.gov registry record · Phase 2
Mechanistic Study of Duloxetine in Breast Cancer Patients With Chronic Pain
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
NCT01912612: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT01912612 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01912612, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
Study Summary
Early stage breast cancer is typically treated with surgery, chemotherapy, radiation therapy, and/or endocrine therapy. Following treatment, 25-60% of breast cancer survivors have reported chronic pain, which can be difficult to manage. Duloxetine is a serotonin norepinephrine reuptake inhibitor that is FDA approved for treatment of depression, anxiety, fibromyalgia, diabetic neuropathic pain, knee arthritis, and low back pain. Pilot data suggest that duloxetine is effective in management of endocrine therapy-associated musculoskeletal pain, and a randomized placebo controlled trial of duloxetine has demonstrated efficacy for treatment of chemotherapy-induced neuropathic pain. In this mechanistic study of duloxetine, we will investigate the change in pain sensitivity with treatment in order to evaluate both why duloxetine is effective for management of pain for some patients, as well as predictors of who is likely to benefit from duloxetine. A total of 84 women with early stage breast cancer who have chronic pain following treatment, as well as 48 women who are pain free, will be enrolled. All subjects will undergo assessment of pain sensitivity and complete questionnaires. Subjects with pain will be treated with duloxetine for a total of 7 weeks, with pain sensitivity assessments before treatment and after 4 weeks of full-dose treatment.
Primary Outcome
Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory. * Baseline: Mean worst pain for all individual patients in arm 1 (intervention) and arm 2 (control) * 5 weeks: Mean worst pain for all individual patients in arm 1 (intervention) * Range of pain score 0-10 (0=no pain; 10=worst pain)
Interventions
- DRUG Duloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2013-10-30 |
| Est. Completion | 2019-06-28 |
| Phase | Phase 2 |
What the finished NCT01912612 record still lists
NCT01912612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which Duloxetine is the first listed.
NCT01912612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01912612 about?
NCT01912612 is a clinical study titled "Mechanistic Study of Duloxetine in Breast Cancer Patients With Chronic Pain". Early stage breast cancer is typically treated with surgery, chemotherapy, radiation therapy, and/or endocrine therapy. Following treatment, 25-60% of breast cancer survivors have reported chronic pain, which can be difficult to manage. Duloxetine is a serotonin norepinephrine reuptake inhibitor tha...
What is the current status of trial NCT01912612?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2013-10-30. Estimated completion is 2019-06-28.
What interventions are being tested in trial NCT01912612?
The interventions under investigation include: Duloxetine (DRUG).
Who is sponsoring clinical trial NCT01912612?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01912612's enrollment target sits among peer trials
82 830th of 2000 higher than 1,167 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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