[Show abstract][Hide abstract] ABSTRACT: 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 11/2007; 110(9):2110-8. DOI:10.1002/cncr.23008 · 4.89 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Purpose We investigated how treatment-induced neuropathic symptoms are associated with patients' quality of life (QOL) and clinician-reported difficulty in caring for patients. Methods Data were obtained from 3,106 outpatients with colorectal, breast, lung, or prostate cancer on numbness/ tingling (N/T), neuropathic pain, and QOL. Clinicians report-ed the degree of difficulty in caring for patients' physical and psychological symptoms. Results For all patients, moderate to severe N/T was associat-ed with poor QOL (OR=1.82, 95 % CI=1.47–2.26, P<0.001) but neuropathic pain was not (OR=1.31, 95 % CI=0.94–1.83, P=0.114). Moderate to severe N/T and neuropathic pain were associated with increased care difficulty (OR=1.49, 95 % CI= 1.27–1.74, P<0.001 for N/T, and OR=1.46, 95 % CI=1.15– 1.84, P=0.002 for neuropathic pain). The association of neu-ropathic pain with care difficulty was most significant in patients with colorectal cancer (CRC) (OR=2.32, 95 % CI= 1.41–3.83, P = 0.001). Baseline neuropathic pain was associated with declining QOL in CRC patients (OR=2.08, 95 % CI=1.21–3.58, P=0.008). Conclusions Clinicians may experience increased care diffi-culty for patients of all cancer types with moderate to severe N/T or neuropathic pain; care difficulty due to neuropathic pain may be higher for CRC patients. Nearly half the patients of all cancer types with moderate to severe N/T may expect poor short-term QOL; CRC—but not other—patients with baseline neuropathic pain are likely to experience declining QOL. Implications for Cancer Survivors About half of patients with moderate to severe N/T (any cancer type) may expect poor QOL in the short term; CRC patients with baseline neuropath-ic pain in particular may experience declining QOL.
Journal of Cancer Survivorship 07/2014; 10.1007/s11764-014-0379-x. DOI:10.1007/s11764-014-0379-x · 3.30 Impact Factor
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