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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765309
First Posted: January 10, 2013
Last Update Posted: January 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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 Intervention
Breast Cancer Procedure: Bilateral mastectomy with reconstruction

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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


Enrollment: 23
Study Start Date: March 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01765309     History of Changes
Other Study ID Numbers: 08-0782
First Submitted: January 8, 2013
First Posted: January 10, 2013
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