Evaluation of the effect of N-acetylcysteine on the prevention and amelioration of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study
Khalefa, HG; May Ahmed Shawki; Aboelhassan, R; El Wakeel, LM;
Abstract
Purpose: The aim of the current study was to evaluate the effect of N-acetylcysteine (NAC) on the incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients. Method: A prospective randomized controlled open label study was conducted on 75 breast cancer patients receiving adjuvant paclitaxel 80 mg/m2 weekly for 12 weeks. Eligible patients were randomized to either the low dose group; 1200 mg daily NAC, the high dose group; 1200 mg NAC twice daily or the control group; received paclitaxel only. The primary endpoint was the incidence of different grades of PIPN using National Cancer Institute’s common toxicity criteria for adverse event (NCI-CTCAE) while secondary endpoints were the severity of PIPN using modified total neuropathy score (mTNS), quality of life (QOL) using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-NTX) subscale, serum nerve growth factor (NGF), and serum malondialdehyde (MDA). Results: At the end of the 12-week period, the incidence of grade (2, 3) peripheral neuropathy was significantly lower in the high dose group (28.6%) compared to the low dose group (61.9%) and the control group (100%), p value < 0.001. A significant improvement in the mTNS and QOL scores was observed after 6 and 12 weeks in the high dose group and the low dose group compared to the control, p value < 0.001. Significantly higher levels of serum NGF in the high dose group and lower level of serum MDA in the high dose and the low dose group were observed. Conclusion: Oral NAC (1200 mg once and twice daily) might reduce the incidence and severity of PIPN and improve the patients’ QOL. Trial registry: Clinical Trial.gov registration number: NCT03492047.
Other data
Title | Evaluation of the effect of N-acetylcysteine on the prevention and amelioration of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study | Authors | Khalefa, HG; May Ahmed Shawki ; Aboelhassan, R; El Wakeel, LM | Keywords | Paclitaxel;N-Acetylcysteine;Peripheral neuropathy;Oxidative stress;Nerve growth factor;OXIDATIVE STRESS;FUNCTIONAL-ASSESSMENT;RISK-FACTORS;CHEMOTHERAPY;ONCOLOGY;PAIN;MALONDIALDEHYDE;NEUROTOXICITY;VALIDATION;MANAGEMENT | Issue Date | 29-Jun-2020 | Publisher | SPRINGER | Journal | Breast cancer research and treatment | Volume | 183 | Start page | 117 | End page | 125 | ISSN | 0167-6806 | DOI | 10.1007/s10549-020-05762-8 | PubMed ID | 32601973 | Scopus ID | 2-s2.0-85087301590 | Web of science ID | WOS:000544155500004 |
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