A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy

Abstract

Abstract. The present study aimed to evaluate the efficacy and safety of acetyl-L-carnitine (ALC) for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). The study was carried out as a prospective, randomized, double-blind, placebo-controlled and paralleled clinical study. A total of 239 patients with CIPN were selected as the study subjects. Of the 239 subjects, 118 subjects received 3 g/day ALC orally for 8 weeks and 121 received a placebo. The primary endpoint was improvement of peripheral neuropathy by at least one grade. Patient status was assessed at week 4, 8 and 12 after enrollment into the study. In both the full analysis set (FAS) and the per-protocol set (PPS), peripheral sensory neuropathy was significantly ameliorated in the ALC group with 50.5 and 51.6% patients meeting the primary endpoint at week 8, compared with 24.1 and 23.1% of patients in the placebo group (P<0.001 in both sets). Secondary endpoints, such as the nerve electrophysiological examination and the Karnofsky physical score were also significantly improved in patients receiving ALC treatment, as compared with the placebo group (FAS, P= 0.0463 and P= 0.022; PPS, P= 0.0076 and P= 0.0064, respectively). Cancer-associated fatigue was significantly alleviated following ALC treatment in the PPS (P= 0.0135). In the safety analysis set, the difference in adverse events incidence between the two groups was not statistically significant (P= 0.3903). There were only two severe adverse events in the ALC group, which were not associated with the effect of ALC. In conclusion, the results of the present study demonstrated that in Chinese patients with cancer, oral administration of ALC is effective at ameliorating peripheral sensory neuropathy induced by chemotherapy, as well as reducing of cancer-associated fatigue and improving physical conditions.

Acylcarnitines: Nomenclature, Biomarkers, Therapeutic Potential, Drug Targets, and Clinical Trials

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Integrative neuromuscular medicine: Neuropathy and neuropathic pain: Consider the alternatives

“…There is mixed evidence for ALC in chemotherapy‐induced peripheral neuropathy (CIPN). Two RCTs showed reduced severity of neuropathy symptoms and incidence of severe neuropathy when patients were treated with ALC during chemotherapy. These trials involved patients receiving sagopilone or a mixed population receiving ALC with chemotherapy.…”

<p>Acetyl-L-carnitine in painful peripheral neuropathy: a systematic review</p>

“…A prospective, double-blind, Class II RCT study totaling 239 patients with chemotherapy-induced peripheral neuropathy tested the effect of oral administration of ALC 3 g/day 34. This study considered as primary endpoint the improvement of peripheral neuropathy by at least one grade according to the National Cancer Institute Common Toxicity Criteria version 3.0.…”

“…A double-blind, randomized placebo-controlled study, totaling 239 patients with chemotherapy-induced peripheral neuropathy, reported a meaningful increase of sural nerve conduction velocity after ALC treatment 34…”