دورية أكاديمية
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.
العنوان: | 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. |
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المؤلفون: | Khalefa HG; Oncology Clinical Pharmacy Department, Nasser Institute for Research and Treatment, Cairo, Egypt., Shawki MA; Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. mayahmed@pharma.asu.edu.eg., Aboelhassan R; Nasser Institute for Research and Treatment, Cairo, Egypt., El Wakeel LM; Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. |
المصدر: | Breast cancer research and treatment [Breast Cancer Res Treat] 2020 Aug; Vol. 183 (1), pp. 117-125. Date of Electronic Publication: 2020 Jun 29. |
نوع المنشور: | Comparative Study; Journal Article; Randomized Controlled Trial |
اللغة: | English |
بيانات الدورية: | Publisher: Kluwer Academic Country of Publication: Netherlands NLM ID: 8111104 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-7217 (Electronic) Linking ISSN: 01676806 NLM ISO Abbreviation: Breast Cancer Res Treat Subsets: MEDLINE |
أسماء مطبوعة: | Publication: Dordrecht : Kluwer Academic Original Publication: The Hague ; Boston : M. Nijhoff, c1981- |
مواضيع طبية MeSH: | Acetylcysteine/*therapeutic use , Antineoplastic Agents, Phytogenic/*adverse effects , Breast Neoplasms/*drug therapy , Paclitaxel/*adverse effects , Peripheral Nervous System Diseases/*prevention & control, Adult ; Aged ; Antineoplastic Agents, Phytogenic/administration & dosage ; Antineoplastic Agents, Phytogenic/therapeutic use ; Biomarkers ; Breast Neoplasms/blood ; Breast Neoplasms/complications ; Chemotherapy, Adjuvant ; Drug Administration Schedule ; Female ; Humans ; Kaplan-Meier Estimate ; Lipid Peroxidation/drug effects ; Malondialdehyde/blood ; Middle Aged ; Nerve Growth Factor/blood ; Paclitaxel/administration & dosage ; Paclitaxel/therapeutic use ; Peripheral Nervous System Diseases/blood ; Peripheral Nervous System Diseases/chemically induced ; Peripheral Nervous System Diseases/drug therapy ; Prospective Studies ; Quality of Life |
مستخلص: | 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/m 2 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. |
فهرسة مساهمة: | Keywords: N-Acetylcysteine; Nerve growth factor; Oxidative stress; Paclitaxel; Peripheral neuropathy |
سلسلة جزيئية: | ClinicalTrials.gov NCT03492047 |
المشرفين على المادة: | 0 (Antineoplastic Agents, Phytogenic) 0 (Biomarkers) 4Y8F71G49Q (Malondialdehyde) 9061-61-4 (Nerve Growth Factor) P88XT4IS4D (Paclitaxel) WYQ7N0BPYC (Acetylcysteine) |
تواريخ الأحداث: | Date Created: 20200701 Date Completed: 20210212 Latest Revision: 20210212 |
رمز التحديث: | 20221213 |
DOI: | 10.1007/s10549-020-05762-8 |
PMID: | 32601973 |
قاعدة البيانات: | MEDLINE |
تدمد: | 1573-7217 |
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DOI: | 10.1007/s10549-020-05762-8 |