Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3).
BACKGROUND
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).


METHODS
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.


RESULTS
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.


CONCLUSIONS
This trial failed to demonstrate any benefit to using gabapentin to treat symptoms caused by CIPN.
Rao
Ravi D
RD
Department of Medical Oncology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA. roa.ravi@mayo.edu
Michalak
John C
JC
Sloan
Jeff A
JA
Loprinzi
Charles L
CL
Soori
Gamini S
GS
Nikcevich
Daniel A
DA
Warner
David O
DO
Novotny
Paul
P
Kutteh
Leila A
LA
Wong
Gilbert Y
GY
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000588:Amines / Q000627:therapeutic use*; D000700:Analgesics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D018592:Cross-Over Studies; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D000077206:Gabapentin; D006801:Humans; D008297:Male; D008875:Middle Aged; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced* / Q000188:drug therapy*; D015990:Placebo Effect; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use*
D000588:Amines; D000700:Analgesics; D000970:Antineoplastic Agents; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin