Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction
Keywords
Abstract
Description
Consecutively enrolled eligible women will be randomized into one of two different treatment groups: 1) Group receiving BTX-A, and 2) Group receiving a placebo. All consenting subjects will be randomized to receive either a single injection of 100 units of BTX-A, or a placebo (saline water), during surgery in the pectoralis major muscle on the operated side once the mastectomy and the breast reconstruction have been completed. Expected duration of subject participation is 4 months.
Dates
Last Verified: | 08/31/2019 |
First Submitted: | 04/12/2012 |
Estimated Enrollment Submitted: | 05/01/2012 |
First Posted: | 05/03/2012 |
Last Update Submitted: | 09/16/2019 |
Last Update Posted: | 10/09/2019 |
Date of first submitted results: | 04/09/2019 |
Date of first submitted QC results: | 09/16/2019 |
Date of first posted results: | 10/09/2019 |
Actual Study Start Date: | 07/31/2012 |
Estimated Primary Completion Date: | 07/17/2017 |
Estimated Study Completion Date: | 07/17/2017 |
Condition or disease
Intervention/treatment
Drug: Group A - Botulinum Toxin Type A
Drug: Group B - Placebo
Phase
Arm Groups
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 | Drug: Group A - Botulinum Toxin Type A |
Placebo Comparator: Group B - Placebo 5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast | Drug: Group B - Placebo 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | Female |
Accepts Healthy Volunteers | Yes |
Criteria | 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 |
Outcome
Primary Outcome Measures
1. Change From Baseline in Average Pain Scores Using a Numeric Pain Intensity Scale [preoperative visit, first postoperative visit (1-2 weeks post surgery)]
2. Physical Well-Being Using the BREAST-Q, Reconstruction Module [first post-operative visit (1-2 weeks post surgery)]
Secondary Outcome Measures
1. Initial Intraoperative Fill Volume in Milliliters (mL) [Single intra-operative measurement at first surgery]
2. Number of Tissue Expansion Visits [up to 24 weeks post-operatively]
3. Total Volume of Tissue Expansion [Up to 24 weeks post-operatively]
4. Rate of Reconstruction Failure [6 months after first surgery]