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NCT01591746 · ClinicalTrials.gov registry record · Phase 3
Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction
A Phase 3 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
NCT01591746: Completed Phase 3 study, sponsored by Mayo Clinic.
NCT01591746 is a Phase 3 study that has completed, run by Mayo Clinic. The registered enrollment target is 131 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01591746, a Phase 3 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
Study Summary
Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast reconstruction. Implant-based breast reconstruction is frequently achieved in two-stages. The first stage consists of the placement of a tissue expander after mastectomy. This is followed by a period of biweekly tissue expansions that can last several months. In the second stage, the tissue expander is removed in a surgical procedure and replaced with a permanent breast implant. Tissue expansion is a well-established breast reconstruction technique characterized by high success rates and high patient satisfaction. Despite the well-recognized advantages of this successful breast reconstruction technique, the subpectoral placement of a tissue expander is associated with significant pain and discomfort in the immediate post-operative period and during the phase of tissue expansion. Pectoralis major muscle spasm is a frequently reported problem during tissue expansion. Legeby et al. recently showed that women who underwent prosthetic breast reconstruction had higher pain scores and took more analgesics that those who did not choose post-mastectomy reconstruction. In the past 10 years, publications on the use of botulinum toxin A (BTX-A) for pain relief in a wide array of clinical conditions have increased tremendously. BTX-A is one of the neurotoxins produced by Clostridium botulinum bacteria. By reversibly inhibiting neurotransmitter release, BTX-A has both analgesic and paralytic properties. The analgesic action of BTX-A was initially thought to be related to its effects on muscular contraction. However, a recent in vitro study of embryonic rat dorsal neurons did confirm that BTX-A inhibits release of substance P, a neurotransmitter associated with pain and inflammatory reactions. The presence of analgesic properties of BTX-A is increasingly supported by s
Interventions
- DRUG Placebo
- DRUG Botulinum Toxin Type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2012-08 |
| Est. Completion | 2017-07-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01591746
The ClinicalTrials.gov registry entry for NCT01591746 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01591746 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01591746 about?
NCT01591746 is a clinical study titled "Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction". Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast reconstruction. Implant-based breast reconstruction is frequently achieved in two-sta...
What is the current status of trial NCT01591746?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2012-08. Estimated completion is 2017-07-18.
What interventions are being tested in trial NCT01591746?
The interventions under investigation include: Placebo (DRUG), Botulinum Toxin Type A (DRUG).
Who is sponsoring clinical trial NCT01591746?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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