Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer, Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/21/2017 |
| Start Date: | August 2012 |
| End Date: | July 18, 2017 |
Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial
Each year, the number of breast cancer survivors who choose post-mastectomy breast
reconstruction keeps rising. Among women who elect to pursue breast reconstruction,
approximately 75% will choose prosthetic breast reconstruction. Implant-based breast
reconstruction is frequently achieved in two-stages. The first stage consists of the
placement of a tissue expander after mastectomy. This is followed by a period of biweekly
tissue expansions that can last several months. In the second stage, the tissue expander is
removed in a surgical procedure and replaced with a permanent breast implant. Tissue
expansion is a well-established breast reconstruction technique characterized by high success
rates and high patient satisfaction. Despite the well-recognized advantages of this
successful breast reconstruction technique, the subpectoral placement of a tissue expander is
associated with significant pain and discomfort in the immediate post-operative period and
during the phase of tissue expansion. Pectoralis major muscle spasm is a frequently reported
problem during tissue expansion. Legeby et al. recently showed that women who underwent
prosthetic breast reconstruction had higher pain scores and took more analgesics that those
who did not choose post-mastectomy reconstruction.
In the past 10 years, publications on the use of BTX-A for pain relief in a wide array of
clinical conditions have increased tremendously. BTX-A is one of the neurotoxins produced by
Clostridium botulinum bacteria. By reversibly inhibiting neurotransmitter release, BTX-A has
both analgesic and paralytic properties. The analgesic action of BTX-A was initially thought
to be related to its effects on muscular contraction. However, a recent in vitro study of
embryonic rat dorsal neurons did confirm that BTX-A inhibits release of substance P, a
neurotransmitter associated with pain and inflammatory reactions. The presence of analgesic
properties of BTX-A is increasingly supported by several clinical observations: pain relief
with BTX-A injections has been reported for migraine headaches, chronic pelvic, chronic
tennis elbow, and post-operative pain control for lower limb lengthening correction, among
others.
This aspect has never been studied in breast cancer survivors who elect to pursue breast
reconstruction with tissue expanders. Furthermore, physical function outcomes are important
to consider with BTX-A use because the link between temporary muscle paralysis and
improvements in participation in daily activities is not a given.
The investigators propose to complete a double-blinded prospective randomized controlled
trial of women undergoing unilateral and bilateral mastectomies with immediate placement of
tissue expanders, to establish the efficacy and safety of BTX-A in alleviating pain and in
improving physical well-being during the expansion period.
reconstruction keeps rising. Among women who elect to pursue breast reconstruction,
approximately 75% will choose prosthetic breast reconstruction. Implant-based breast
reconstruction is frequently achieved in two-stages. The first stage consists of the
placement of a tissue expander after mastectomy. This is followed by a period of biweekly
tissue expansions that can last several months. In the second stage, the tissue expander is
removed in a surgical procedure and replaced with a permanent breast implant. Tissue
expansion is a well-established breast reconstruction technique characterized by high success
rates and high patient satisfaction. Despite the well-recognized advantages of this
successful breast reconstruction technique, the subpectoral placement of a tissue expander is
associated with significant pain and discomfort in the immediate post-operative period and
during the phase of tissue expansion. Pectoralis major muscle spasm is a frequently reported
problem during tissue expansion. Legeby et al. recently showed that women who underwent
prosthetic breast reconstruction had higher pain scores and took more analgesics that those
who did not choose post-mastectomy reconstruction.
In the past 10 years, publications on the use of BTX-A for pain relief in a wide array of
clinical conditions have increased tremendously. BTX-A is one of the neurotoxins produced by
Clostridium botulinum bacteria. By reversibly inhibiting neurotransmitter release, BTX-A has
both analgesic and paralytic properties. The analgesic action of BTX-A was initially thought
to be related to its effects on muscular contraction. However, a recent in vitro study of
embryonic rat dorsal neurons did confirm that BTX-A inhibits release of substance P, a
neurotransmitter associated with pain and inflammatory reactions. The presence of analgesic
properties of BTX-A is increasingly supported by several clinical observations: pain relief
with BTX-A injections has been reported for migraine headaches, chronic pelvic, chronic
tennis elbow, and post-operative pain control for lower limb lengthening correction, among
others.
This aspect has never been studied in breast cancer survivors who elect to pursue breast
reconstruction with tissue expanders. Furthermore, physical function outcomes are important
to consider with BTX-A use because the link between temporary muscle paralysis and
improvements in participation in daily activities is not a given.
The investigators propose to complete a double-blinded prospective randomized controlled
trial of women undergoing unilateral and bilateral mastectomies with immediate placement of
tissue expanders, to establish the efficacy and safety of BTX-A in alleviating pain and in
improving physical well-being during the expansion period.
Consecutively enrolled eligible women will be randomized into one of two different treatment
groups: 1) Group receiving BTX-A, and 2) Group receiving a placebo. All consenting subjects
will be randomized to receive either a single injection of 100 units of BTX-A, or a placebo
(saline water), during surgery in the pectoralis major muscle on the operated side once the
mastectomy and the breast reconstruction have been completed. Expected duration of subject
participation is 4 months.
groups: 1) Group receiving BTX-A, and 2) Group receiving a placebo. All consenting subjects
will be randomized to receive either a single injection of 100 units of BTX-A, or a placebo
(saline water), during surgery in the pectoralis major muscle on the operated side once the
mastectomy and the breast reconstruction have been completed. Expected duration of subject
participation is 4 months.
Inclusion:
1. Women at least 18 years of age, who will undergo immediate unilateral or bilateral
tissue expander breast reconstruction following therapeutic skin-sparing or
nipple-sparing mastectomy.
2. Women at least 18 years of age, who will undergo immediate bilateral tissue expanders
breast reconstruction following risk-reduction (prophylactic) skin-sparing or
nipple-sparing mastectomy.
Exclusion:
1. Subjects who are unable to read or speak English.
2. Breast reconstruction using the latissimus dorsi flap combined with a tissue expander.
3. Documented diagnosis of chronic pain, upper limb spasticity, cervical dystonia,
axillary hyperhidrosis, strabismus or blepharospasm;
4. Hypersensitivity to any botulinum toxin preparation or to any of the components in the
formulation.
5. Infection at the proposed site of injection.
6. Pre-existing neuromuscular disorders (including diagnosed myasthenia gravis,
Eaton-Lambert syndrome, or amyotrophic lateral sclerosis).
7. Aminoglycosides intake at the time of surgery (these antibiotics can potentiate the
effect of BTX-A).
8. Women who are pregnant or breast feeding.
9. Presence of breast implants from previous breast surgery.
10. Reported use of Botox within 4 months prior to planned surgical date.
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