Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT01938846 - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors Phase 1
Recruiting NCT06058312 - Individual Food Preferences for the Mediterranean Diet in Cancer Patients N/A
Completed NCT03308942 - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants Phase 2
Recruiting NCT06018311 - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads N/A
Withdrawn NCT05431439 - Omics of Cancer: OncoGenomics
Completed NCT01343043 - A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma Phase 1
Completed NCT01938638 - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer Phase 1
Recruiting NCT05514444 - Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001) Phase 1
Recruiting NCT02292641 - Beyond TME Origins N/A
Terminated NCT00954512 - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004) Phase 1/Phase 2
Recruiting NCT04958239 - A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) Phase 1
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Completed NCT01222728 - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Active, not recruiting NCT05636696 - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue N/A
Not yet recruiting NCT06035549 - Resilience in East Asian Immigrants for Advance Care Planning Discussions N/A
Recruiting NCT06004466 - Noninvasive Internal Jugular Venous Oximetry
Completed NCT02909348 - Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab