NCT00686127

Brief Summary

This trial is part of a larger, longitudinal study of symptoms that occur in the breast surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a lidocaine patch that they will wear on a daily basis for 12 weeks. We hypothesize that women who wear the lidocaine patch will report a decrease in pain and decreased interference with function compared to women who wear the placebo patch.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

May 1, 2014

Completed
Last Updated

June 28, 2018

Status Verified

April 1, 2014

Enrollment Period

4.3 years

First QC Date

May 27, 2008

Results QC Date

February 14, 2014

Last Update Submit

April 27, 2018

Conditions

Neuropathic PainPostmastectomy Pain

Keywords

breast cancerneuropathic paintopical lidocainepostmastectomy painbreast symptomsbreast pain

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks

    Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).

    Baseline, 12 weeks

Secondary Outcomes (1)

  • Pain Interference With Function

    12 weeks

Study Arms (2)

Lidocaine Patch

ACTIVE COMPARATOR

Drug: lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.

Drug: Lidoderm patch

Placebo Patch

PLACEBO COMPARATOR

Drug: placebo patch, 1 patch was applied topically to the affected site(s) for 12 hours each day.

Drug: Placebo patch

Interventions

Lidoderm patchDRUG

1 patch was applied topically to the affected site(s) for 12 hours each day.

Also known as: Lidoderm, Lidoaine patch 5%
Lidocaine Patch
Placebo patchDRUG

1 patch was applied topically to the affected site(s) for 12 hours each day.

Placebo Patch

Eligibility Criteria

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

You may qualify if:

  • Adult women \>18 years who develop neuropathic pain in the breast scar area and/or ipsilateral arm following breast cancer surgery
  • Has a healed incision(s)
  • Has no recurrent disease in the painful area
  • Is able to read, write and understand English

You may not qualify if:

  • Presence of another type of pain that is more severe than the neuropathic pain
  • Use of an opioid analgesic of greater than 60 mg codeine/day
  • Is actively trying to become pregnant
  • Has a medical contraindication to the use of lidocaine
  • Has an allergy to lidocaine
  • Is taking a coanalgesic for neuropathic pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

NeuralgiaBreast NeoplasmsMastodynia

Interventions

LidocaineLidoderm

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Christine Miaskowski, PI
Organization
University of California, San Francisco
chris.miaskowski@nursing.ucsf.edu
415-476-9407

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 29, 2008

Study Start

September 1, 2003

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 28, 2018

Results First Posted

May 1, 2014

Record last verified: 2014-04

Locations

US(1)