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A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders

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ClinicalTrials.gov Identifier: NCT01765309
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Investigation of whether injection of the pectoralis muscle with 100 units botulinum toxin during breast reconstruction with tissue expanders results in decreased pain using a blinded, randomized, controlled trial.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Bilateral mastectomy with reconstruction Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders
Study Start Date : March 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012


Arm Intervention/treatment
Experimental: Bilateral mastectomy with reconstruction
The trial was a comparison between each breast in a single patient undergoing bilateral mastectomy with reconstruction
Procedure: Bilateral mastectomy with reconstruction
In each patient enrolled in the study, botulinum toxin was injected into one pectoralis muscle while saline placebo was injected on the opposite side in a randomized blinded fashion
Other Name: Botulinum toxin (botox) injection



Primary Outcome Measures :
  1. Difference between preoperative and postoperative pain scale [ Time Frame: 12 weeks ]
    Patients reported pain in each breast on a visual analog scale of 1-10 at each clinic visit



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral mastectomy with immediate tissue expander reconstruction

Exclusion Criteria:

  • Unwilling to receive study injections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765309


Locations
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Joyce K Aycock, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01765309     History of Changes
Other Study ID Numbers: 08-0782
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: January 14, 2013
Last Verified: March 2012

Keywords provided by University of Colorado, Denver:
Tissue expanders
Botulinum toxin
Botox

Additional relevant MeSH terms:
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents