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

July 28, 2016 updated by: University of British Columbia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1N1
        • Recruiting
        • Plastic, Reconstructive and Cosmetic Surgery
        • Sub-Investigator:
          • Adrian Lee, MD, FRCSC
        • Sub-Investigator:
          • Paul Oxley, MD, FRCSC
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Canada, British Columbia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sheina A Macadam, MD FRCSC MHS
        • Sub-Investigator:
          • Peter A Lennox, MD FRCSC
        • Sub-Investigator:
          • Nancy Van Laeken, MD FRCSC
        • Principal Investigator:
          • Adelyn L Ho, MD MPH
        • Sub-Investigator:
          • Perry Gdalevitch, MD, FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients who undergo immediate, post-mastectomy, unilateral or bilateral, tissue expander/implant reconstruction
  • Patients older than 21, with no upper age limit
  • English-speaking, or has an appropriate translator

Exclusion Criteria:

  • Patient declines inclusion in the study
  • Patients who undergo a single-stage implant reconstruction or combined autogenous tissue expander/implant reconstruction
  • Previous history of radiation
  • Previous breast surgery with implants
  • Previous history of axillary lymph node dissection
  • Patients who are pregnant
  • Patients with hepatorenal failure
  • Patients with known hypersensitivity to Botulinum Toxin-A
  • Patients with significant mastectomy flap ischemia at time of tissue expander placement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Expander Placement, Botulinum Toxin-A
During surgery, administered only once, 5 cc in 5 different locations on chest muscle.
Drug: Botulinum Toxin-A
100 Units diluted in 25cc saline
Other Names:
  • Botulinum Toxin Type A
Placebo Comparator: Tissue expander Placement WITH Saline
During surgery, administered only once, 5 cc in 5 different locations on chest muscle.
Drug: Saline
Dispensed in a 25cc syringe
Other Names:
  • 0.9% Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Quality of life and patient satisfaction using the Breast-Q
Time Frame: Before 1st surgery, 2 weeks, ~6-8weeks, Before 2nd Surgery, 6 months, and 12 months post-op
The Breast-Q© is a patient reported outcome measure (PROM) for breast surgery that was rigorously developed to accurately measure patient reported satisfaction and quality of life (QOL). (http://www.mskcc.org/mskcc/shared/Breast-Q/index.html). The BREAST-Q was developed and validated with adherence to international guidelines. This PROM is composed of six scales that address: 1) psychosocial well-being, 2) physical well-being, 3) sexual well-being, 4) satisfaction with breasts, 5) satisfaction with outcome, and 6) satisfaction with care.
Before 1st surgery, 2 weeks, ~6-8weeks, Before 2nd Surgery, 6 months, and 12 months post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported pain,using the BPI (Brief Pain Inventory) and Pain Diary during the expansion phase (initial to final expansion) and in the long-term period (6 and 12 months).
Time Frame: BPI (before 1st surgery, day of surgery, 2 weeks, ~ 6 - 8 weeks, before 2nd surgery, 6 months and 12 months). After 1st surgery, pain diary is to be filled out every evening at the same time.

The BPI is a common patient-reported instrument used to assess clinical pain. The BPI assesses the severity of pain and the impact of pain on daily functions in patients with pain from chronic diseases or conditions or acute conditions (i.e. postoperative pain).

The question asked on the daily pain diary will be derived from the BPI: "Every evening at the same time, please rate the worst pain you've experienced in the last 24 hours when 0 represents no pain and 10 represents the most severe pain imaginable".
BPI (before 1st surgery, day of surgery, 2 weeks, ~ 6 - 8 weeks, before 2nd surgery, 6 months and 12 months). After 1st surgery, pain diary is to be filled out every evening at the same time.
Aesthetic outcome
Time Frame: 6 months and 12 months (after 2nd surgery)
Aesthetic results can be evaluated using different methods: patient-reported aesthetic satisfaction (Breast-Q) and aesthetic outcome from the perspective of the health professional. Standardized photographs using a three-category, five-item Breast Aesthetic Score. This scoring scheme separates the various components of the aesthetic results of the breast into different subscale thus allowing the rating to be more explicit. This score has not been validated, but has demonstrated good inter- and intra-rater reliability.
6 months and 12 months (after 2nd surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Fraser Health
Providence Health & Services
Vancouver Coastal Health

Investigators

  • Principal Investigator: Adelyn Ho, MD, MPH, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

September 1, 2011

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10-03166

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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