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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:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01765309
First received: January 8, 2013
Last updated: January 10, 2013
Last verified: March 2012
History of Changes
  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: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Difference between preoperative and postoperative pain scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01765309     History of Changes
Other Study ID Numbers: 08-0782
Study First Received: January 8, 2013
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013