Tags

Type your tag names separated by a space and hit enter

Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3).
Cancer. 2007 Nov 01; 110(9):2110-8.C

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.

Authors+Show Affiliations

Department of Medical Oncology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA. roa.ravi@mayo.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

17853395

Citation

Rao, Ravi D., et al. "Efficacy of Gabapentin in the Management of Chemotherapy-induced Peripheral Neuropathy: a Phase 3 Randomized, Double-blind, Placebo-controlled, Crossover Trial (N00C3)." Cancer, vol. 110, no. 9, 2007, pp. 2110-8.
Rao RD, Michalak JC, Sloan JA, et al. Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer. 2007;110(9):2110-8.
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. (2007). Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer, 110(9), 2110-8.
Rao RD, et al. Efficacy of Gabapentin in the Management of Chemotherapy-induced Peripheral Neuropathy: a Phase 3 Randomized, Double-blind, Placebo-controlled, Crossover Trial (N00C3). Cancer. 2007 Nov 1;110(9):2110-8. PubMed PMID: 17853395.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: 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 L, AU - Soori,Gamini S, AU - Nikcevich,Daniel A, AU - Warner,David O, AU - Novotny,Paul, AU - Kutteh,Leila A, AU - Wong,Gilbert Y, AU - ,, PY - 2007/9/14/pubmed PY - 2007/12/12/medline PY - 2007/9/14/entrez SP - 2110 EP - 8 JF - Cancer JO - Cancer VL - 110 IS - 9 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. SN - 0008-543X UR - https://www.unboundmedicine.com/medline/citation/17853395/Efficacy_of_gabapentin_in_the_management_of_chemotherapy_induced_peripheral_neuropathy:_a_phase_3_randomized_double_blind_placebo_controlled_crossover_trial__N00C3__ L2 - https://doi.org/10.1002/cncr.23008 DB - PRIME DP - Unbound Medicine ER -