title: A prospective, randomized, multi-center trial to investigate Actovegin in prevention and treatment of acute oral mucositis caused by chemoradiotherapy for nasopharyngeal carcinoma.
abstract: OBJECTIVE
  A multi-center prospective randomized trial was conducted to evaluate the efficacy and safety of Actovegin in the prevention and treatment of chemoradiotherapy-induced acute oral mucositis.
  
  
  METHODS
  Between February 2006 and May 2007, 156 evaluable patients with nasopharyngeal carcinoma were randomized to Group 1 (n=53) for prevention, Group 2 (n=51) for treatment, and Group 3 (n=52) for control. All patients received concomitant chemoradiotherapy ± induction chemotherapy. Radiation technique and dose were similar among 3 groups. Intravenous Actovegin of 30 ml daily (5 days/week) was administrated from day 1 of the radiotherapy for Group 1 and from the onset of grade 2 mucositis for Group 2, until the end of the radiotherapy.
  
  
  RESULTS
  The incidence of grade 3 mucositis was lower in Group 1 compared with Group 3 (26.4% vs. 55.8%, P=0.002). Group 2 had a lower progression rate of mucositis from grade 2 to 3 compared with Group 3 (39.2% vs. 60.4%, P=0.035). There was no difference in the onset time of grade 3 mucositis among 3 groups. Actovegin was well tolerated and no treatment-related adverse events were observed.
  
  
  CONCLUSIONS
  Actovegin is effective in the prevention and treatment of chemoradiotherapy-induced oral mucositis.
authors.affiliation: Department of Radiation Oncology, Cancer Center, Sun Yat-Sen University, Guangzhou, China. wushaox@mail.sysu.edu.cn
authors.forename: Shao-Xiong
authors.initials: SX
authors.lastname: Wu
authors.forename: Tian-Tian
authors.initials: TT
authors.lastname: Cui
authors.forename: Chong
authors.initials: C
authors.lastname: Zhao
authors.forename: Jian-Ji
authors.initials: JJ
authors.lastname: Pan
authors.forename: Bing-Yu
authors.initials: BY
authors.lastname: Xu
authors.forename: Ye
authors.initials: Y
authors.lastname: Tian
authors.forename: Nian-Ji
authors.initials: NJ
authors.lastname: Cui
mesh_terms: D000704:Analysis of Variance; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage; D016009:Chi-Square Distribution; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006418:Heme / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D011446:Prospective Studies; D011837:Radiation-Protective Agents / Q000627:therapeutic use*; D013280:Stomatitis / Q000209:etiology* / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D011837:Radiation-Protective Agents; D006418:Heme; C015646:Actovegin; D016190:Carboplatin; D002945:Cisplatin; D005472:Fluorouracil