Symptom Management After Breast Cancer Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00686127
First received: May 27, 2008
Last updated: April 2, 2014
Last verified: April 2014
  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: Parallel 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:


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

Primary Outcome Measures:
  • Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Pain Interference With Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: September 2003
Study Completion Date: December 2013
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lidocaine Patch
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
1 patch was applied topically to the affected site(s) for 12 hours each day.
Other Name: Lidoderm, Lidoaine patch 5%
Placebo Comparator: Placebo Patch
Drug: placebo patch, 1 patch was applied topically to the affected site(s) for 12 hours each day.
Drug: Placebo patch
1 patch was applied topically to the affected site(s) for 12 hours each day.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: February 14, 2014
Last Updated: April 2, 2014
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 July 28, 2014