The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial
- 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.
- Arm I: Patients receive oral lamotrigine once daily for 2 weeks and then twice daily
for 8 weeks.
- Arm II: Patients receive oral placebo once daily for 2 weeks and then twice daily for 8
In both arms, treatment continues for 10 weeks in the absence of unacceptable toxicity.
Quality of life, pain, mood states, and symptom distress are assessed at baseline and at 4,
6, 8, and 10 weeks.
Patients are followed at 3-7 days.
PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Ravi D. Rao, MD, MBBS
United States: Federal Government
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|MBCCOP - Hawaii||Honolulu, Hawaii 96813|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Atlanta Regional||Atlanta, Georgia 30342-1701|
|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 - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|CCOP - Duluth||Duluth, Minnesota 55805|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Dayton||Kettering, Ohio 45429|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|
|Coborn Cancer Center||Saint Cloud, Minnesota 56303|
|Cancer Care Center at Medcenter One Hospital||Bismarck, North Dakota 58501|
|Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center||Sioux City, Iowa 51101|