NCT01765309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
Last Updated

January 14, 2013

Status Verified

March 1, 2012

Enrollment Period

3.3 years

First QC Date

January 8, 2013

Last Update Submit

January 10, 2013

Conditions

Breast Cancer

Keywords

Tissue expandersBotulinum toxinBotox

Outcome Measures

Primary Outcomes (1)

  • Difference between preoperative and postoperative pain scale

    Patients reported pain in each breast on a visual analog scale of 1-10 at each clinic visit

    12 weeks

Study Arms (1)

Bilateral mastectomy with reconstruction

EXPERIMENTAL

The trial was a comparison between each breast in a single patient undergoing bilateral mastectomy with reconstruction

Procedure: Bilateral mastectomy with reconstruction

Interventions

Bilateral mastectomy with reconstructionPROCEDURE

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

Also known as: Botulinum toxin (botox) injection
Bilateral mastectomy with reconstruction

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral mastectomy with immediate tissue expander reconstruction

You may not qualify if:

  • Unwilling to receive study injections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Plastic Surgery ProceduresBotulinum ToxinsBotulinum Toxins, Type AInjections

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Joyce K Aycock, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 10, 2013

Study Start

March 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 14, 2013

Record last verified: 2012-03

Locations

US(1)