Neoplasms

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Breast Neoplasms

Skin Diseases

Breast Diseases

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Vitamins

Vitamin A

Retinol palmitate

Botulinum Toxins

Botulinum Toxins, Type A

abobotulinumtoxinA

Acetylcholine

Cholinergic Agents

Neurotransmitter Agents

Retinol

During surgery, administered only once, 5 cc in 5 different locations on chest muscle.

Botulinum Toxin-A

Saline

Adelyn L Ho, MD MPH

Joline T Choi, MBBS, MHS

Adrian Lee, MD, FRCSC

Paul Oxley, MD, FRCSC

Joline T Choi, MBBS MHS

Sheina A Macadam, MD FRCSC MHS

Peter A Lennox, MD FRCSC

Nancy Van Laeken, MD FRCSC

Perry Gdalevitch, MD, FRCSC

Adelyn Ho, MD, MPH

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.

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.

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

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

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.

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 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.

Vancouver Coastal Health

Providence Health & Services

Fraser Health

University of British Columbia

All patients will undergo placement of a temporary tissue expander immediately following mastectomy.Patients will undergo the surgical creation of an expander pocket using implantable Alloderm.

Alloderm, Questionnaires

A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.

Without ALLODERM, Questionnaires

Joseph Disa, MD

Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest.

Following your surgery, the tissue expander is gradually filled with salt water over a period of months. Once the expander is filled to the size of your new breast, a second operation is performed. At this time, the tissue expander is removed and a permanent breast implant is placed. This is a standard procedure. We are interested in learning about the use of AlloDerm in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in order to cover and protect a tissue expander. We want to know if the use of AlloDerm can decrease your pain or discomfort after surgery and after the filling of your tissue expander.

AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your body to reject it are removed. When it is placed in your chest, your own cells will then grow into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will either have reconstruction with AlloDerm or without AlloDerm.

Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial

The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial

University of Michigan

University of North Carolina, Chapel Hill

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Use of Botulinum Toxin A in Two-Stage Tissue Expander/ Implant Breast Reconstruction	NCT01427400	Breast Neoplasm... Neoplasms by Si... Neoplasms Breast Diseases Skin Diseases	Botulinum Toxin... Saline	21 Years -	University of British Columbia
Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial	NCT00639106	Breast Cancer	Alloderm, Quest... Without ALLODER...	21 Years - 75 Years	Memorial Sloan Kettering Cancer Center
Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial	NCT00639106	Breast Cancer	Alloderm, Quest... Without ALLODER...	21 Years - 75 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for breast expander