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

Phase 4
21 Years
Open (Enrolling)
Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases

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Trial Information

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

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Change from Baseline in Quality of life and patient satisfaction using the Breast-Q

Outcome Description:

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). ( 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.

Outcome Time Frame:

Before 1st surgery, 2 weeks, ~6-8weeks, Before 2nd Surgery, 6 months, and 12 months post-op

Safety Issue:


Principal Investigator

Adelyn Ho, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of British Columbia


Canada: Ethics Review Committee

Study ID:




Start Date:

October 2011

Completion Date:

March 2014

Related Keywords:

  • Breast Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Breast Diseases
  • Skin Diseases
  • Breast expander
  • Breast reconstruction
  • Implants
  • Botox
  • Breast Neoplasms
  • Breast Diseases
  • Neoplasms
  • Neoplasms by Site
  • Skin Diseases