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N-Acetyl Cysteine for Prevention of Oral Mucositis in Hematopoietic Sct: A Double-Blind, Randomized, Placebo-Controlled Trial Publisher



Moslehi A1, 2 ; Taghizadehghehi M3 ; Gholami K1, 3 ; Hadjibabaie M1, 3 ; Jahangardrafsanjani Z1, 3 ; Sarayani A3 ; Javadi M1, 3 ; Esfandbod M4 ; Ghavamzadeh A4
Authors
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Authors Affiliations
  1. 1. Clinical Pharmacy Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran 1417614411, Iran
  2. 2. Clinical Pharmacy Department, Faculty of Pharmacy, Esfahan University of Medical Sciences, Esfahan, Iran
  3. 3. Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Hematology-Oncology and Stem Cell Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran

Source: Bone Marrow Transplantation Published:2014


Abstract

Oral mucositis (OM) is a complication of high-dose chemotherapy (HDC) which is frequently observed in hematopoietic SCT settings. Antioxidant agents have been proposed to prevent OM and therefore N-acetyl cysteine (NAC) could have an important role. In the present study, we conducted a double-blind, randomized, placebo-controlled study to evaluate the NAC effect on OM incidence and severity, and also glutathione peroxidase-1 activity. Leukemia patients undergoing allogeneic hematopoietic SCT preceded by HDC were recruited into the study and received either NAC (100 mg/kg/day) (n=38) or placebo (n=42) from the starting day of HDC until day +15 after transplantation. OM was evaluated daily for 21 days after transplantation according to World Health Organization oral toxicity scale. The incidence of severe OM (grades 3-4) was significantly lower in the NAC group (23.7% vs 45.3%, P=0.04). Moreover, the mean duration of OM was significantly shorter in the intervention group (6.24(2.96) vs 8.12(3.97) days, P=0.02). The glutathione peroxidase-1 activity was also significantly higher in the NAC group seven days after transplantation (3.38(2.19) vs 2.41(1.70) ng/mL, P=0.003). It is concluded that parenteral NAC is effective in reducing the incidence of severe cases and the total duration of OM. © 2014 Macmillan Publishers Limited. All rights reserved.