title: N-acetyl cysteine for prevention of oral mucositis in hematopoietic SCT: a double-blind, randomized, placebo-controlled trial.
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.
authors.affiliation: 1] Clinical Pharmacy Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran [2] Clinical Pharmacy Department, Faculty of Pharmacy, Esfahan University of Medical Sciences, Esfahan, Iran.
authors.forename: A
authors.initials: A
authors.lastname: Moslehi
authors.affiliation: Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Taghizadeh-Ghehi
authors.affiliation: 1] Clinical Pharmacy Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran [2] Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: K
authors.initials: K
authors.lastname: Gholami
authors.affiliation: 1] Clinical Pharmacy Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran [2] Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Hadjibabaie
authors.affiliation: 1] Clinical Pharmacy Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran [2] Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Z
authors.initials: Z
authors.lastname: Jahangard-Rafsanjani
authors.affiliation: Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: A
authors.initials: A
authors.lastname: Sarayani
authors.affiliation: 1] Clinical Pharmacy Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran [2] Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Javadi
authors.affiliation: Hematology-Oncology and Stem cell Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Esfandbod
authors.affiliation: Hematology-Oncology and Stem cell Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: A
authors.initials: A
authors.lastname: Ghavamzadeh
mesh_terms: D000111:Acetylcysteine / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D064591:Allografts; D000975:Antioxidants / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005979:Glutathione Peroxidase / Q000097:blood; D019337:Hematologic Neoplasms / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013280:Stomatitis / Q000209:etiology / Q000517:prevention & control*; D055815:Young Adult; D000094765:Glutathione Peroxidase GPX1
chemical_list: D000975:Antioxidants; D005979:Glutathione Peroxidase; D000111:Acetylcysteine; D000094765:Glutathione Peroxidase GPX1; C000722067:GPX1 protein, human