Pain Clinical Trial
Official title:
The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial
RATIONALE: Lamotrigine may be effective in reducing pain, numbness, tingling, and other
symptoms of peripheral neuropathy. It is not yet known whether lamotrigine is effective in
treating peripheral neuropathy caused by chemotherapy.
PURPOSE: This randomized phase III trial is studying how well lamotrigine works in reducing
pain, numbness, tingling, and other symptoms of peripheral neuropathy caused by chemotherapy
in patients with cancer.
OBJECTIVES:
- Compare the efficacy of lamotrigine vs placebo in reducing pain and symptoms of
chemotherapy-induced peripheral neuropathy in patients with cancer.
- Compare symptom distress, mood states, functional abilities, and overall quality of life
of patients treated with these agents.
- Determine the toxic effects of lamotrigine in these patients.
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are
stratified according to neurotoxic chemotherapy received (taxanes vs platinum-based compounds
vs vinca alkaloids vs combination vs other), status of neurotoxic chemotherapy (actively
receiving therapy vs discontinued or completed), and duration of pain or neuropathy symptoms
(1-3 months vs 3-6 months vs more than 6 months). Patients are randomized to 1 of 2 treatment
arms.
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