- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01591746
Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction
Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial
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 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A - Botulinum Toxin Type A
100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast
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Other Names:
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Placebo Comparator: Group B - Placebo
5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast
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5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Average Pain Scores Using a Numeric Pain Intensity Scale
Time Frame: preoperative visit, first postoperative visit (1-2 weeks post surgery)
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The numeric pain intensity scale (NPIS) will be completed at the preoperative visit and again at the first postoperative visit.
The NPIS is a visual analog scale (VAS) commonly used to assess clinical pain.
Subjects are asked to rate their pain on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
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preoperative visit, first postoperative visit (1-2 weeks post surgery)
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Physical Well-Being Using the BREAST-Q, Reconstruction Module
Time Frame: first post-operative visit (1-2 weeks post surgery)
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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.
The Reconstruction module Physical Well-Being scale has questions on the function and participation in activities before and after breast reconstruction.
For this study, subjects were asked to answer 16 questions on how often they experienced each symptom, using score of 1 to 5, where 1 was none of the time and 5 was very often.
Answers from these questions were combined to provide a total physical well-being score (for a total possible range of 16-80) for each patient at each visit.
Lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction.
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first post-operative visit (1-2 weeks post surgery)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial Intraoperative Fill Volume in Milliliters (mL)
Time Frame: Single intra-operative measurement at first surgery
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The amount of initial intraoperative fill volume in milliliters (mL) in the tissue expander at the time of surgery divided by the manufacturers recommended total tissue expander volume will be measured.
Each breast will be measured separately.
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Single intra-operative measurement at first surgery
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Number of Tissue Expansion Visits
Time Frame: up to 24 weeks post-operatively
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The total number of tissue expansion visits completed post-operatively.
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up to 24 weeks post-operatively
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Total Volume of Tissue Expansion
Time Frame: Up to 24 weeks post-operatively
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Measurement of total expansion volume in milliliters (mL).
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Up to 24 weeks post-operatively
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Rate of Reconstruction Failure
Time Frame: 6 months after first surgery
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The rate of reconstruction failure will be measured by the number of subjects who have tissue expander removal.
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6 months after first surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Valerie Lemaine, MD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Breast Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- 11-001687
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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