The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Charles L. Loprinzi, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000069098
NCT00027963
February 2002
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Mayo Clinic | Jacksonville, Florida 32224 |
Medcenter One Health System | Bismarck, North Dakota 58501 |
CentraCare Health Plaza | Saint Cloud, Minnesota 56303 |
Altru Cancer Center | Grand Forks, North Dakota 58206 |
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |