Symptom Management After Breast Cancer Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Trial (RDBPCT) of the Effectiveness of the Lidocaine Patch in the Management of Neuropathic Pain After Breast Cancer Surgery

Conditions
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Neuropathic Pain, Postmastectomy Pain

Intervention / Treatment
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* Drug: Lidoderm patch
* Drug: Placebo patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine Patch<br>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<br>* 1 patch was applied topically to the affected site(s) for 12 hours each day.<br>* Other names: Lidoderm, Lidoaine patch 5%;|
| Placebo Comparator: Placebo Patch<br>Drug: placebo patch, 1 patch was applied topically to the affected site(s) for 12 hours each day. | Drug: Placebo patch<br>* 1 patch was applied topically to the affected site(s) for 12 hours each day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Interference With Function |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, neuropathic pain, topical lidocaine, postmastectomy pain, breast symptoms, breast pain