Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
RATIONALE: Gabapentin may be effective in relieving pain and other symptoms of peripheral neuropathy. It is not yet known if gabapentin is effective in treating peripheral neuropathy in cancer patients undergoing chemotherapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of gabapentin in treating pain and other symptoms of peripheral neuropathy in cancer patients undergoing chemotherapy.
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial|
|Study Start Date:||February 2002|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
- Determine whether gabapentin improves the pain and other symptoms in cancer patients with chemotherapy-induced peripheral neuropathy.
- Determine the effect of this drug on symptom distress, mood states, functional abilities, and overall quality of life in these patients.
- Determine the toxic effects of this drug in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to neurotoxic chemotherapy (active vs nonactive and discontinued vs completed) and neurotoxic chemotherapeutic agents (vinca alkaloids vs taxanes vs platinum-based compounds vs combination of two or more of the above agents). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive titrating doses of oral gabapentin twice daily and then three times daily for 3 weeks. Patients then receive a fixed dose of oral gabapentin three times daily for 3 weeks. Patients cross-over to therapy as in arm II at week 8.
- Arm II: Patients receive titrating doses of oral placebo and then a fixed dose of oral placebo as in arm I. Patients cross-over to therapy as in arm I at week 8.
Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.