Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-31 @ 6:37 AM
Study NCT ID:
NCT00058357
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2003-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
The Efficacy Of Lidocaine Patch In The Management Of Postsurgical Neuropathic Pain In Patients With Cancer: A Phase III Double-Blind, Crossover Study
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: