Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase IV	Supportive care	Active	18 and over	Other	Breast Pain CA107091, NCT00686127

Trial Description

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

UCSF Helen Diller Family Comprehensive Cancer Center

Christine A Miaskowski, RN, PhD		Ph: 415-476-9407
		Email: chris.miaskowski@nursing.ucsf.edu

Claudia West, RN, MS		Ph: 415-476-5131
		Email: claudia.west@nursing.ucsf.edu

U.S.A.
California
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Christine A Miaskowski, RN, PhD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00686127
Information obtained from ClinicalTrials.gov on March 18, 2009