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Symptom Management After Breast Cancer Surgery

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ClinicalTrials.gov Identifier: NCT00686127
Recruitment Status : Completed
First Posted : May 29, 2008
Results First Posted : May 1, 2014
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Postmastectomy Pain Drug: Lidoderm patch Drug: Placebo patch Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2003
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks [ Time Frame: Baseline, 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).


Secondary Outcome Measures :
  1. Pain Interference With Function [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686127


Locations
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United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00686127    
Other Study ID Numbers: Breast Pain
CA107091
First Posted: May 29, 2008    Key Record Dates
Results First Posted: May 1, 2014
Last Update Posted: June 28, 2018
Last Verified: April 2014
Keywords provided by University of California, San Francisco:
breast cancer
neuropathic pain
topical lidocaine
 postmastectomy pain
breast symptoms
breast pain
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action