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NCT01255631 · ClinicalTrials.gov registry record · Phase 4
Pulsed Electromagnetic Fields (PEMF) and Post-Axillary Surgery Morbidity
A Phase 4 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
NCT01255631 is a Phase 4 study that was terminated before completion, run by Columbia University. The registered enrollment target is 22 participants.
The verdict
NCT01255631, a Phase 4 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
Study Summary
The most important prognostic indicator for the breast cancer patient is the axillary lymph node status. With the introduction of the sentinel lymph node biopsy, many women were spared the morbidity of a full axillary lymph node dissection(ALND) while having the axillary nodes assessed with a low false negative rate. Approximately 30% of women who undergo ALND experience shoulder/arm morbidity including numbness, pain, weakness and decreased range of motion. In addition, the sentinel lymph node dissection (SLND) held the promise that women with early stage breast cancer would be able to avoid the dreaded morbidity associated with axillary lymph node dissections including lymphedema, decreased range of motion and pain. Since the adoption of SLN, numerous papers have documented that SLN is superior to ALND. However, patients who undergo SLN still have a significant amount of pain with this procedure. There are few published studies which objectively assess the subjective and objective symptoms of SLND. Pulsed electromagnetic fields (PEMF) have been shown to be effective in the treatment of fractures and spinal fusion, relief of pain in acute sprains and whiplash injuries, improvement of skin blood flow, healing of venous stasis ulcers, and reduction of postmastectomy lymphedema. Indeed, radiofrequency PEMF devices are FDA approved for pain and edema relief. PEMF devices are economical and disposable, and can be incorporated unobtrusively in standard post-op dressings. We have recently reported, in a double-blind, placebo-controlled study on breast reduction, that post-op PEMF therapy produced a significant decrease in pain and pain medication use, along with a concomitant decrease in IL1-beta in the wound bed.1 The current pilot study will be designed to determine if PEMF treatment, given in addition to standard of care, can reduce post-operative discomfort and morbidity after lumpectomy and SLND, or lumpectomy and ALND. Lumpectomy and ALND/SLND patients enrolled in
Interventions
- DEVICE Sham PEMF Device
- DEVICE PEMF Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01255631
The ClinicalTrials.gov registry entry for NCT01255631 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham PEMF Device is the first listed.
NCT01255631 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01255631 about?
NCT01255631 is a clinical study titled "Pulsed Electromagnetic Fields (PEMF) and Post-Axillary Surgery Morbidity". The most important prognostic indicator for the breast cancer patient is the axillary lymph node status. With the introduction of the sentinel lymph node biopsy, many women were spared the morbidity of a full axillary lymph node dissection(ALND) while having the axillary nodes assessed with a low fa...
What is the current status of trial NCT01255631?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2010-10. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01255631?
The interventions under investigation include: Sham PEMF Device (DEVICE), PEMF Device (DEVICE).
Who is sponsoring clinical trial NCT01255631?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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