Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction
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Purpose
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 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 several clinical observations: pain relief with BTX-A injections has been reported for migraine headaches, chronic pelvic, chronic tennis elbow, and post-operative pain control for lower limb lengthening correction, among others.
This aspect has never been studied in breast cancer survivors who elect to pursue breast reconstruction with tissue expanders. Furthermore, physical function outcomes are important to consider with BTX-A use because the link between temporary muscle paralysis and improvements in participation in daily activities is not a given.
The investigators propose to complete a double-blinded prospective randomized controlled trial of women undergoing unilateral and bilateral mastectomies with immediate placement of tissue expanders, to establish the efficacy and safety of BTX-A in alleviating pain and in improving physical well-being during the expansion period.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Pain, Postoperative BRCA1 Mutation BRCA2 Mutation Breast Diseases Neoplasms |
Drug: Botulinum Toxin Type A Drug: Sodium Chloride Solution |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial |
- Change from Baseline in average pain scores using a numeric pain intensity scale [ Time Frame: Pre-operative visit, first post-operative visit, subsequent plastic surgery appointments/expansion visits for a period of approximately 4 months. ] [ Designated as safety issue: No ]The numeric pain intensity scale (NPIS) will be completed at various time frames. The NPIS is a visual analog scale commonly used to assess clinical pain.
- Change from Baseline in Physical Well-Being using the BREAST-Q Physical Well-Being scale [ Time Frame: Pre-operative visit, first post-operative visit, subsequent plastic surgery appointments/expansion visits for a period of approximately 4 months. ] [ Designated as safety issue: No ]The Physical Well-Being scale of the BREAST-Q, reconstruction module, will be used for this purpose. The BREAST-Q is a validated patient-reported outcome measure to accurately assess quality of life and patient satisfaction.
- Initial percent volume expansion intra-operatively [ Time Frame: Single intra-operative measurement at first surgery ] [ Designated as safety issue: No ]The amount of initial intraoperative fill volume in the tissue expander at the time of surgery divided by the manufacturers recommended total tissue expander volume will be measured.
- Rate of tissue expansion [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]Measurement of expansion volume at each tissue expansion and number of tissue expansions completed.
- Rate of reconstruction failure [ Time Frame: At 6 months after first surgery ] [ Designated as safety issue: Yes ]Determine the rate of tissue expander removal.
- Incidence of side effects attributable to the injection of BTX-A at doses of 100 units and 200 units. [ Time Frame: First 30 days postoperatively ] [ Designated as safety issue: Yes ]All serious adverse events will be recorded and reported. Minor adverse events and unusual complications encountered during the postoperative period will be carefully recorded.
| Estimated Enrollment: | 128 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Botulinum Toxin A
|
Drug: Botulinum Toxin Type A
100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride in the pectoralis major muscle in each operated breast.
Other Name: BOTOX
|
|
Placebo Comparator: Group B
Placebo
|
Drug: Sodium Chloride Solution
5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast.
|
Detailed Description:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion:
- Women at least 18 years of age, who will undergo immediate unilateral or bilateral tissue expander breast reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy.
- Women at least 18 years of age, who will undergo immediate bilateral tissue expanders breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy.
Exclusion:
- Subjects who are unable to read or speak English.
- Breast reconstruction using the latissimus dorsi flap combined with a tissue expander.
- Documented diagnosis of chronic pain, upper limb spasticity, cervical dystonia, axillary hyperhidrosis, strabismus or blepharospasm;
- Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
- Infection at the proposed site of injection.
- Pre-existing neuromuscular disorders (including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis).
- Aminoglycosides intake at the time of surgery (these antibiotics can potentiate the effect of BTX-A).
- Women who are pregnant or breast feeding.
- Presence of breast implants from previous breast surgery.
- Reported use of Botox within 4 months prior to planned surgical date.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01591746
| Contact: Valerie Lemaine, MD | 507-284-2736 | lemaine.valerie@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Valerie Lemaine, MD, MPH lemaine.valerie@mayo.edu | |
| Principal Investigator: | Valerie Lemaine, MD | Mayo Clinic |
More Information
| Responsible Party: | Valerie Lemaine, Principal Investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01591746 History of Changes |
| Other Study ID Numbers: | 11-001687 |
| Study First Received: | April 13, 2012 |
| Last Updated: | September 29, 2016 |
| Health Authority: | United States: Food and Drug Administration |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by Mayo Clinic:
|
Mastectomy Mammaplasty Breast reconstruction Tissue expansion |
Botulinum toxins, Type A Quality of Life Acellular dermal matrix |
Additional relevant MeSH terms:
|
Pain, Postoperative Breast Diseases Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms Skin Diseases Botulinum Toxins Botulinum Toxins, Type A |
AbobotulinumtoxinA OnabotulinumtoxinA IncobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on September 30, 2016