Pain Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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