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

Ravi D. Rao, John C. Michalak, Jeff A Sloan, Charles Lawrence Loprinzi, Gamini S. Soori, Daniel A. Nikcevich, David Oman Warner, Paul Novotny, Leila A. Kutteh, Gilbert Y. Wong

Research output: Contribution to journalArticle

222 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2110-2118
Number of pages9
JournalCancer
Volume110
Issue number9
DOIs
StatePublished - Nov 1 2007

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Peripheral Nervous System Diseases
Cross-Over Studies
Placebos
Drug Therapy
Anticonvulsants
Linear Models
gabapentin
Students
Pain
Therapeutics

Keywords

  • Carboplatin
  • Chemotherapy-induced peripheral neuropathy
  • Cisplatin
  • Gabapentin
  • Neurotoxicity
  • Paclitaxel
  • Pain
  • Peripheral neuropathy
  • Taxanes
  • Vinca alkaloids

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy : A phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). / Rao, Ravi D.; Michalak, John C.; Sloan, Jeff A; Loprinzi, Charles Lawrence; Soori, Gamini S.; Nikcevich, Daniel A.; Warner, David Oman; Novotny, Paul; Kutteh, Leila A.; Wong, Gilbert Y.

In: Cancer, Vol. 110, No. 9, 01.11.2007, p. 2110-2118.

Research output: Contribution to journalArticle

Rao, Ravi D. ; Michalak, John C. ; Sloan, Jeff A ; Loprinzi, Charles Lawrence ; Soori, Gamini S. ; Nikcevich, Daniel A. ; Warner, David Oman ; Novotny, Paul ; Kutteh, Leila A. ; Wong, Gilbert Y. / Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy : A phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). In: Cancer. 2007 ; Vol. 110, No. 9. pp. 2110-2118.
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abstract = "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.",
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T1 - Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy

T2 - A phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3)

AU - Rao, Ravi D.

AU - Michalak, John C.

AU - Sloan, Jeff A

AU - Loprinzi, Charles Lawrence

AU - Soori, Gamini S.

AU - Nikcevich, Daniel A.

AU - Warner, David Oman

AU - Novotny, Paul

AU - Kutteh, Leila A.

AU - Wong, Gilbert Y.

PY - 2007/11/1

Y1 - 2007/11/1

N2 - 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.

AB - 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.

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KW - Cisplatin

KW - Gabapentin

KW - Neurotoxicity

KW - Paclitaxel

KW - Pain

KW - Peripheral neuropathy

KW - Taxanes

KW - Vinca alkaloids

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DO - 10.1002/cncr.23008

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C2 - 17853395

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VL - 110

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JO - Cancer

JF - Cancer

SN - 0008-543X

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