Phase III randomised trialA prospective, randomized, multi-center trial to investigate Actovegin in prevention and treatment of acute oral mucositis caused by chemoradiotherapy for nasopharyngeal carcinoma
Section snippets
Eligibility criteria
Eligibility criteria for this study included the following: patients with newly diagnosed stage III–IVB (UICC 2002 staging criteria) NPC scheduled for CRT, age 18–70 years, a Karnofsky performance score ⩾ 70, no significant oral disease, and normal cardiac, hepatic, renal, and hematopoietic functions. Pretreatment evaluation included a complete history and physical examination, complete blood count, and blood chemistry analysis. Staging evaluations included a CT scan or MRI of the nasopharynx and
Results
A total of 160 patients at 4 participating treatment centers entered into the trial and were randomized into Group 1 (n = 53), Group 2 (n = 55) and Group 3 (n = 52) between February 2006 and May 2007. Four patients in Group 2 were considered ineligible for an efficacy analysis. Of these 4 patients, 2 withdrew from study at their request after the first or the third dose of Actovegin, another 2 did not have oral mucositis ⩾ grade 2 during chemoradiotherapy and hence Actovegin was not administered.
Discussion
Oral mucosa is composed of stratified squamous epithelia that are renewed quickly and are highly sensitive to irradiation. Radiotherapy often causes oral acute mucositis characterized by oral erythema, pseudomembrane, necrosis/ulceration, and pain. Acute mucositis is thought to be a complex biologic process, involving direct damage to the dividing cells of the oral epithelium with the depletion of the basal epithelium and inhibition of the proliferation of transit cells [15], [16].
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Conclusions
In summary, our results show that intravenous Actovegin is effective in the prevention and treatment of oral mucositis induced by CRT. Actovegin reduces the severity of oral mucositis and decreases the incidence of severe pain. The efficacy of preventive application appears to be better than therapeutic application.
Conflict of interest statement
The authors claimed no conflict of interest in relation to this manuscript.
Acknowledgements
We thank Nycomed China Limited to provide the study drug Actovegin, and Daniel T.T. Chua, F.R.C.R., Departments of Clinical Oncology, University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China, for his assistance in English editing and recommendations.
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