The Use of Botulinum Toxin-A in Two-stage Tissue Expander/Implant Breast Reconstruction: A Prospective, Randomized, Double-Blind Placebo Controlled Trial
21 Years
N/A
Female
Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases
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
placement
Type of Study:
Interventional
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). (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.
Outcome Time Frame:
Before 1st surgery, 2 weeks, ~6-8weeks, Before 2nd Surgery, 6 months, and 12 months post-op
Safety Issue:
No
Principal Investigator
Adelyn Ho, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of British Columbia
Authority:
Canada: Ethics Review Committee
Study ID:
H10-03166
NCT ID:
NCT01427400
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
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