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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of British Columbia
Sponsor:
Collaborators:
Vancouver Coastal Health
Providence Health & Services
Fraser Health
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01427400
First received: August 18, 2011
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Drug: Botulinum Toxin-A
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Botulinum Toxin-A in Two-stage Tissue Expander/Implant Breast Reconstruction: A Prospective, Randomized, Double-Blind Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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".


  • Aesthetic outcome [ Time Frame: 6 months and 12 months (after 2nd surgery) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 128
Study Start Date: October 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 0.9% Sodium Chloride

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427400

Contacts
Contact: Adelyn L Ho, MD MPH 604-773-5466 adelynh@interchange.ubc.ca
Contact: Janice G Giang, B.Sc. (Hons) 604-875-4111 ext 68489 janice.giang@ubc.ca

Locations
Canada, British Columbia
Plastic, Reconstructive and Cosmetic Surgery Recruiting
Surrey, British Columbia, Canada, V3V 1N1
Sub-Investigator: Adrian Lee, MD, FRCSC         
Sub-Investigator: Paul Oxley, MD, FRCSC         
Canada, British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Adelyn L Ho, MD MPH    604-773-5466    adelynh@interchange.ubc.ca   
Contact: Janice G Giang, BSc    604-875-4111 ext 68489    janice.giang@ubc.ca   
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         
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health
Providence Health & Services
Fraser Health
Investigators
Principal Investigator: Adelyn Ho, MD, MPH University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01427400     History of Changes
Other Study ID Numbers: H10-03166
Study First Received: August 18, 2011
Last Updated: January 28, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of British Columbia:
Breast expander
Breast reconstruction
Implants
Botox

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014