Symptom Management After Breast Cancer Surgery

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686127
• Other study ID #: Breast Pain
• Secondary ID: CA107091
• Status: Completed
• Phase: Phase 4
• Start date: September 2003
• Est. completion date: December 2007

Study information

• Verified date: April 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Neuralgia
• Neuropathic Pain
• Postmastectomy Pain

Intervention

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

Locations

Country	Name	City	State
United States	UCSF Comprehensive Cancer Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Interference With Function		12 weeks