This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-35103, CA-63849, CA-63848, CA-35195, CA-35272, CA-35269, CA-5101, CA-60276, CA-52352, CA-37417, CA-35448.
Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy†
A phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3)
Article first published online: 12 SEP 2007
Copyright © 2007 American Cancer Society
Volume 110, Issue 9, pages 2110–2118, 1 November 2007
How to Cite
Rao, R. D., Michalak, J. C., Sloan, J. A., Loprinzi, C. L., Soori, G. S., Nikcevich, D. A., Warner, D. O., Novotny, P., Kutteh, L. A., Wong, G. Y. and and the North Central Cancer Treatment Group (2007), Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy. Cancer, 110: 2110–2118. doi: 10.1002/cncr.23008
Presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO), Orlando, Florida, May 13–17, 2005.
Additional participating institutions include Iowa Oncology Research Association CCOP, Des Moines, Iowa (Roscoe F. Morton, MD); Rapid City Regional Oncology Group, Rapid City, South Dakota (Larry P. Ebbert, MD); Mayo Clinic Scottsdale CCOP, Scottsdale, Arizona (Robert F. Marschke Jr, MD); CentraCare Clinic, St. Cloud, Minnesota (Harold E. Windschitl, MD); Geisinger Clinical Oncology Program, Danville, Pennsylvania (Suresh Nair, MD); Grand Forks Clinic, Ltd, Grand Forks, North Dakota (John A. Laurie, MD); Metro-Minnesota Community Clinical Oncology Program, Minnesota (Patrick J. Flynn, MD); Quain and Ramstad Clinic, Bismarck, North Dakota (Ferdinand Addo, MD); Meritcare Hospital CCOP, Fargo, North Dakota (Ralph Levitt, MD); Saskatchewan Cancer Foundation, Saskatoon, Saskatchewan, Canada (Maria Tria Tirona, MD); Sioux Community Cancer Consortium, Sioux Falls, South Dakota (Loren K. Tschetter, MD); Wichita Community Clinical Oncology, Wichita, Kansas (Shaker R. Dakhil, MD).
- Issue published online: 18 OCT 2007
- Article first published online: 12 SEP 2007
- Manuscript Accepted: 4 JUN 2007
- Manuscript Revised: 2 MAY 2007
- Manuscript Received: 20 MAR 2007
- peripheral neuropathy;
- chemotherapy-induced peripheral neuropathy;
- vinca alkaloids;
The antiepileptic agent, gabapentin, has been demonstrated to relieve symptoms of peripheral neuropathy due to various etiologies. On the basis of these data, a multicenter, double-blind, placebo-controlled, crossover, randomized trial was conducted to evaluate the effect of gabapentin on symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Patients with symptomatic CIPN who complained of ‘average’ daily pain scores of either 1) ≥4 on a 0–10 numerical rating scale (NRS); or 2) ≥1 on the 0–3 Eastern Cooperative Oncology Group neuropathy scale (ENS) were eligible (higher numbers indicate greater severity of symptoms in both scales). Patients were randomized to receive gabapentin (target dose, 2700 mg) or placebo for 6 weeks. Crossover occurred after a 2-week washout period. CIPN-related symptoms were evaluated weekly by questionnaires. Statistical methods followed established methods for crossover designs, including Student t tests to compare average intrapatient differences between treatments and linear models to adjust for potential concomitant covariates.
There were 115 patients who were randomly assigned to the treatment or control arm. Both groups were well matched by symptoms at study entry. Changes in symptom severity were statistically similar between the 2 groups during the study. Adverse events were mild and similar in both groups.
This trial failed to demonstrate any benefit to using gabapentin to treat symptoms caused by CIPN. Cancer 2007. © 2007 American Cancer Society.