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Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Pain, Postoperative, BRCA1 Mutation, BRCA2 Mutation, Breast Diseases, Neoplasms

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Trial Information

Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial


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 assigned to receive during surgery either a single injection of 100 units of BTX-A,
or a placebo (saline water), 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 up to 12 months, depending on the number of tissue expansion visits
necessary to fill the tissue expander to its final desired volume.

Inclusion Criteria


Inclusion:

1. Women undergoing immediate unilateral or bilateral tissue expander breast
reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy
requiring postoperative expansions;

2. Women undergoing immediate bilateral tissue expanders breast reconstruction following
risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy requiring
postoperative tissue expansions.

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, chronic migraine, 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Change from Baseline in average pain scores using a numeric pain intensity scale

Outcome Description:

The numeric pain intensity scale (NPIS) will be completed at various time frames. The NPIS is a visual analog scale commonly used to assess clinical pain.

Outcome Time Frame:

Pre-operatively, post-opeartively: at 1 week, 2 weeks, at every expansion, at 3 months, and at the follow-up visit prior to the second surgery

Safety Issue:

No

Principal Investigator

Valerie Lemaine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

11-001687

NCT ID:

NCT01591746

Start Date:

August 2012

Completion Date:

August 2015

Related Keywords:

  • Breast Cancer
  • Pain, Postoperative
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Breast Diseases
  • Neoplasms
  • Mastectomy
  • Mammaplasty
  • Breast reconstruction
  • Tissue expansion
  • Botulinum toxins, Type A
  • Quality of Life
  • Acellular dermal matrix
  • Breast Neoplasms
  • Breast Diseases
  • Neoplasms
  • Pain, Postoperative

Name

Location
Mayo Clinic Rochester, Minnesota  55905