A prospective, randomized, multi-center trial to investigate Actovegin in prevention and treatment of acute oral mucositis caused by chemoradiotherapy for nasopharyngeal carcinoma

• Published in: Radiotherapy and oncology 2010-10, Vol.97 (1), p.113-118
• Main Authors: Wu, Shao-Xiong, Cui, Tian-Tian, Zhao, Chong, Pan, Jian-Ji, Xu, Bing-Yu, Tian, Ye, Cui, Nian-Ji
• Format: Article
• Language: English
• Subjects: Actovegin; Analysis of Variance; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carboplatin - administration & dosage; Chemotherapy; Chi-Square Distribution; Cisplatin - administration & dosage; Combined Modality Therapy; Female; Fluorouracil - administration & dosage; Hematology, Oncology and Palliative Medicine; Heme - analogs & derivatives; Heme - therapeutic use; Humans; Male; Middle Aged; Mucositis; Nasopharyngeal carcinoma; Nasopharyngeal Neoplasms - drug therapy; Nasopharyngeal Neoplasms - radiotherapy; Prospective Studies; Radiation-Protective Agents - therapeutic use; Radiotherapy; Stomatitis - etiology; Stomatitis - prevention & control; Treatment Outcome
• ISSN: 0167-8140; 1879-0887
• DOI: 10.1016/j.radonc.2010.08.003

Abstract Purpose 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 and materials 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.