Symptom Management After Breast Cancer Surgery

Phase 4

Completed

• Conditions: Neuropathic Pain; Postmastectomy Pain
• Interventions: Drug: Lidoderm patch; Drug: Placebo patch

• Registration Number: NCT00686127
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-29
• Results First Submitted: 2014-02-14
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-02
• Results First Posted: 2014-05-01
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks	Baseline, 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).

Secondary Outcome Measures

Name	Time	Method
Pain Interference With Function	12 weeks

Trial Locations

Locations (1)

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States