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Evaluation of the Safety and Efficacy of N-acetylcysteine in the Prevention of Paclitaxel-induced Peripheral Neuropathy: A Randomized, Double-blind, and Placebo-controlled Trial

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Evaluation of the Safety and Efficacy of N-acetylcysteine in the Prevention of Paclitaxel-induced Peripheral Neuropathy: A Randomized, Double-blind, and Placebo-controlled Trial

J Res Pharm Pract
2025 Jun 13;14(1):18–26.
doi: 10.4103/jrpp.jrpp_999_25
Author
Sima Ramezaninejad , Ehsan Zaboli , Mohammad Eslamijouybari , Leila Mirzakhani , Fatemeh Shaki , Mahmood Moosazadeh , Hamid Reza Namvar , Amir Mohammad Shabani , Ebrahim Salehifar
Author Information

1Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran

2Department of Hematology/Oncology, Gastrointestinal Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran

3Department of Toxicology, Pharmaceutical Sciences Research Center, Institute of Herbal Medicines and Metabolic Disorders, Mazandaran University of Medical Sciences, Sari, Iran

4Gastrointestinal Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran

5Department of Clinical Pharmacy, Pharmaceutical Sciences Research Center, Institute of Herbal Medicines and Metabolic Disorders, Mazandaran University of Medical Sciences, Sari, Iran

✉Address for correspondence: Prof. Ebrahim Salehifar,

E-mail: esalehifar52@gmail.com

Article notes
Received 2024 Jul 22; Revised 2024 Nov 7; Accepted 2025 Jan 14; Collection date 2025 Jan-Mar.
Copyright and License information

Copyright: © 2025 Journal of Research in Pharmacy Practice

This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

PMC Copyright notice

PMCID: PMC12258537 PMID: 40661819

Abstract
Objective
Paclitaxel-induced peripheral neuropathy (PIPN) is a disabling condition that leads to discontinuation or dose reduction of chemotherapy and reduces the patient’s quality of life (QOL). We investigated the effect of N-acetylcysteine (NAC) in preventing PIPN.
Methods
This study was a randomized, double-blind, and placebo-controlled clinical trial conducted at a chemotherapy center of Mazandaran University of Medical Sciences. Breast cancer patients receiving the Adriamycin/Cyclophosphamide-Taxol regimen were enrolled. All patients received 1200 mg NAC or placebo in two doses before each cycle of paclitaxel. Response to treatment was assessed based on improvements in the Numeric Pain Rating Scale (NRS), NCI-CTCAE, NPS, FACT/GOG-Ntx, and EORTC-QLQ. Two blood samples were taken at baseline and last cycle to determine the oxidative factors.
Findings

Sixty patients were enrolled. At the last cycle, changes in NRS were decreasing in the NAC group but increasing in the placebo group. Thirteen patients (44.8%) in the NAC group and only one patient (3.4%) in the placebo group still reported no neuropathy in the end. A significant difference was observed between the two groups in the Ntx subscale and the Fact-G total score at the last cycle (P < 0.001). The QOL increased in the NAC and decreased in the placebo group. Glutathione levels, MDA, and TAC differed significantly between the two groups (P < 0.001, <0.001, and 0.04, respectively), but no significant difference in NO levels (P = 0.5).

Conclusion

Oral NAC at a dose of 1200 mg daily for two doses can reduce the incidence and severity of PIPN and improve patients’ QOL.

Keywords:

N-acetylcysteine, peripheral neuropathy, Paclitaxel

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