title: A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy.
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.
authors.affiliation: Oncology Department, The 6th People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200233, P.R. China.
authors.forename: Yuanjue
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Oncology Department, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, P.R. China.
authors.forename: Yongqian
authors.initials: Y
authors.lastname: Shu
authors.affiliation: Oncology Department, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu 210008, P.R. China.
authors.forename: Baorui
authors.initials: B
authors.lastname: Liu
authors.affiliation: Oncology Department, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, P.R. China.
authors.forename: Ping
authors.initials: P
authors.lastname: Liu
authors.affiliation: Oncology Department, The First People's Hospital of Changzhou, Changzhou, Jiangsu 213003, P.R. China.
authors.forename: Changping
authors.initials: C
authors.lastname: Wu
authors.affiliation: Oncology Department, The First Affiliated Hospital of BengBu Medical College, Bengbu, Anhui 233004, P.R. China.
authors.forename: Rongsheng
authors.initials: R
authors.lastname: Zheng
authors.affiliation: Surgical Oncology Department, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang 325000, P.R. China.
authors.forename: Xiaohua
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Oncology Department, The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215004, P.R. China.
authors.forename: Zhixiang
authors.initials: Z
authors.lastname: Zhuang
authors.affiliation: Surgical Oncology Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, P.R. China.
authors.forename: Yongchuan
authors.initials: Y
authors.lastname: Deng
authors.affiliation: Oncology Department, Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200092, P.R. China.
authors.forename: Leizhen
authors.initials: L
authors.lastname: Zheng
authors.affiliation: Oncology Department, Shanghai Tenth People's Hospital, Shanghai 200072, P.R. China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Xu
authors.affiliation: Oncology Department, Third People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 201999, P.R. China.
authors.forename: Bin
authors.initials: B
authors.lastname: Jiang
authors.affiliation: Oncology Department, Fuzhou General Hospital of Nanjing Military Command of Chinese PLA, Fuzhou, Fujian 350025, P.R. China.
authors.forename: Xuenong
authors.initials: X
authors.lastname: Ouyang
authors.affiliation: Cancer Hematology Department, Wuhan General Hospital of Guangzhou Military Command of Chinese PLA, Wuhan, Hubei 510000, P.R. China.
authors.forename: Jianfei
authors.initials: J
authors.lastname: Gao
authors.affiliation: Oncology Department, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003, P.R. China.
authors.forename: Nong
authors.initials: N
authors.lastname: Xu
authors.affiliation: Lee's Pharmaceutical (Hong Kong) Ltd., Hong Kong, P.R. China.
authors.forename: Xiaoyi
authors.initials: X
authors.lastname: Li
authors.affiliation: Zhaoke Pharmaceutical (Heifei) Co. Ltd., Hefei, Anhui 230088, P.R. China.
authors.forename: Su
authors.initials: S
authors.lastname: Jiang
authors.affiliation: Lee's Pharmaceutical (Hong Kong) Ltd., Hong Kong, P.R. China.
authors.forename: Chaofan
authors.initials: C
authors.lastname: Liang
authors.affiliation: Oncology Department, The 6th People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200233, P.R. China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Yao
keywords: acetyl-L-carnitine; adverse events; cancer-associated fatigue; chemotherapy-induced peripheral neuropathy; sensory neuropathy