Phase 4 N=21 Randomized Double-blind Supportive Care

Symptom Management After Breast Cancer Surgery

Neuropathic Pain · Postmastectomy Pain

Bottom Line

View on ClinicalTrials.gov: NCT00686127 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks — 4.0 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lidoderm patch (Drug); Placebo patch (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of California, San Francisco
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks	4.0	—
SECONDARY Pain Interference With Function	—	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00686127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.