MedPath

Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery

Phase 3
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Pain
Interventions
Other: placebo
Registration Number
NCT00058357
Lead Sponsor
Alliance for Clinical Trials in Oncology
Brief Summary

RATIONALE: A lidocaine patch may be effective in relieving numbness, tingling, and other symptoms of neuropathy. It is not yet known whether a lidocaine patch is effective in treating neuropathy in patients who have undergone surgery for cancer.

PURPOSE: This randomized phase III trial is studying lidocaine patch to see how well it works compared to a placebo patch in relieving numbness, tingling, and other symptoms of neuropathy in patients who have undergone surgery for cancer.

Detailed Description

OBJECTIVES:

* Determine whether a lidocaine patch vs placebo improves postsurgical neuropathic pain in cancer patients.

* Compare the toxic effects of these regimens in these patients.

* Compare the effect of these regimens on mood states, functional abilities, and overall quality of life of these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to etiology of pain (breast surgery vs lung surgery vs amputation vs other), duration of pain (1-3 months vs 4-6 months vs more than 6 months), and current analgesic regimen (opioids \[including tramadol\] vs antidepressants vs anticonvulsants vs combination vs other vs none). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive a lidocaine transdermal patch (up to 3 patches) applied directly to the painful area for 18 hours once daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity. At the end of week 4, patients cross over to arm II.

* Arm II: Patients receive a placebo transdermal patch applied to the painful area as in arm I. At the end of week 4, patients cross over to arm I.

Pain and quality of life are assessed at baseline and weeks 4 and 8.

Patients are followed at 3-7 days.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Placebo patchplaceboParticipants will be instructed to apply a patch or patches (up to 3 maximum simultaneously) directly to the affected area. The patch(es) should be applied during awake hours and then left on continuously for approximately 18 hours or until usual bedtime sleep.
Lidocaine patchlidocaineParticipants will be instructed to apply a patch or patches (up to 3 maximum simultaneously) directly to the affected area. The patch(es) should be applied during awake hours and then left on continuously for approximately 18 hours or until usual bedtime sleep.
Primary Outcome Measures
NameTimeMethod
Pain intensity rating (NRS)4 and 8 weeks
Secondary Outcome Measures
NameTimeMethod
Pain as assessed by the Brief Pain Inventory-Short Form, Neuropathy Pain Scale, Subject Global Impression of Change, Pain Catastrophizing Scale, Profile of Mood States Short Form, and NCCTG Quality of Life8 weeks
Incidence of each toxicity reported in each treatment period8 weeks
Maximum severity reported of each toxicity8 weeks
Distribution of the overall toxicity score8 weeks
Proportion of patients who report a preference for lidocaine patch or placebo at study completion8 weeks
Proportion of patients who terminate treatment prematurelyup to 8 weeks

Trial Locations

Locations (156)

Mayo Clinic Scottsdale

🇺🇸

Scottsdale, Arizona, United States

Providence Hospital

🇺🇸

Washington, District of Columbia, United States

Mayo Clinic - Jacksonville

🇺🇸

Jacksonville, Florida, United States

MBCCOP-Medical College of Georgia Cancer Center

🇺🇸

Augusta, Georgia, United States

Rush-Copley Cancer Care Center

🇺🇸

Aurora, Illinois, United States

St. Joseph Medical Center

🇺🇸

Bloomington, Illinois, United States

Graham Hospital

🇺🇸

Canton, Illinois, United States

Memorial Hospital

🇺🇸

Carthage, Illinois, United States

Eureka Community Hospital

🇺🇸

Eureka, Illinois, United States

Galesburg Clinic

🇺🇸

Galesburg, Illinois, United States

Scroll for more (146 remaining)
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.