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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014