The Use of Botulinum Toxin A in Two-Stage Tissue Expander/ Implant Breast Reconstruction — Botox  

Neoplasms Clinical Trial

Official title: The Use of Botulinum Toxin-A in Two-stage Tissue Expander/Implant Breast Reconstruction: A Prospective, Randomized, Double-Blind Placebo Controlled Trial

Status Recruiting

Clinical Trial Summary

Breast reconstruction is a common procedure with over 86,000 breast reconstruction procedures performed in the United States in 2009. This is a 1.5-fold increase since 2007. Of these breast reconstructions, 65% use a tissue expander/implant technique. Although satisfactory results can be achieved with a single-stage technique, a two-stage approach is considered more reliable, allowing for precise positioning of the inframammary fold and an opportune time to perform a capsulotomy to increase the breast skin flap by releasing the soft tissue.

The placement of the tissue expander and implant under the chest muscles is thought to minimize the incidence of capsular contracture, expander exposure, and in addition, produce acceptable aesthetic results. However, discomfort is often associated with this submuscular placement of a tissue expander or implant, specifically during the expansion phase. Patients undergoing immediate reconstruction using submuscular implants have been shown to have higher analgesic requirements and to have higher pain scores post-operatively, compared to non-reconstructed patients. An uncomfortable reconstruction can lead to under-filling of the expander, a longer expansion process, abandonment of reconstruction, and a compromised quality of life. The use of Botulinum Toxin A (Botox) injections into the chest muscles at the time of surgery may help ease the discomfort that is often associated with this procedure.

The investigators propose a prospective double-blind randomized placebo-controlled trial of patients undergoing tissue expander/implant reconstruction. The information gathered from this analysis will provide a greater understanding of the effects of Botox in the setting of two-stage tissue expander/implant breast reconstruction, with the goal to improve patient satisfaction and quality of life.

Clinical Trial Description

Currently, there is level C evidence for the efficacy of Botox in the treatment of postoperative pain and muscle spasms in breast reconstruction patients. Additional high-level evidence is necessary to justify the use of Botox in breast cancer patients, which potentially will improve the reconstructive process for these patients and improve quality of life. Additionally, there have been no studies to date that have evaluated patient satisfaction and QOL in this setting. The investigators will evaluate patient satisfaction and QOL using the Breast-Q© during different time periods after two-stage tissue expander/implant reconstruction. Previous studies have demonstrated a reduction in pain when Botox was used during tissue expander/implant breast reconstruction, however, these studies were not blinded which may introduce bias. Additionally, a timely reconstruction is important to the patient, and a decrease in pain may result in a shorter fill interval and an increased total amount of volume in the tissue expander. The investigators will therefore document both the amount of expansion that a patient can tolerate at each follow-up visit and the total volume expanded, and compare the data between the Botox group to the group assigned to placebo. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Diseases
• Breast Neoplasms
• Neoplasms
• Neoplasms by Site
• Skin Diseases

• NCT number: NCT01427400
• Study type: Interventional
• Source: University of British Columbia
• Contact: Adelyn L Ho, MD MPH
• Phone: 604-773-5466
• Email: adelynh@interchange.ubc.ca
• Status: Recruiting
• Phase: Phase 4
• Start date: October 2011
• Completion date: December 2017