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Symptom Management After Breast Cancer Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00686127
First received: May 27, 2008
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Neuropathic Pain
Postmastectomy Pain
 Drug: Lidoderm patch
Drug: Placebo patch
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • pain intensity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain interference with function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: September 2003
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Lidocaine patch
 Drug: Lidoderm patch
One patch is changed every twenty-four hours
Other Name: Lidoderm
Placebo Comparator: 2
Placebo patch
 Drug: Placebo patch
Patch is changed every 24 hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686127

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00686127     History of Changes
Other Study ID Numbers: Breast Pain, CA107091
Study First Received: May 27, 2008
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
breast cancer
neuropathic pain
topical lidocaine
 postmastectomy pain
breast symptoms
breast pain

Additional relevant MeSH terms:
Breast Neoplasms
Neuralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
 Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013