Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
- Registration Number
- NCT00027963
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description placebo placebo 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. gabapentin gabapentin 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. Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.
- Primary Outcome Measures
Name Time Method Change in pain and symptoms Up to 14 weeks
- Secondary Outcome Measures
Name Time Method Quality of life Up to 14 weeks
Trial Locations
- Locations (23)
CentraCare Health Plaza
🇺🇸Saint Cloud, Minnesota, United States
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Altru Cancer Center
🇺🇸Grand Forks, North Dakota, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States