BACKGROUND: the study was designed to test whether vitamin E (VE) provides oral mucosal protection in patients with irradiated cancers of the head and neck. METHODS:Fifty-four patients with cancer of the oral cavity and oropharynx were randomly assigned to rinse the oral cavity in an oil solution containing either VE or placebo before every conventional fraction of 2 Gy and again 8 to 12 hours later during the 5 to 7 weeks of radiotherapy (RT). RESULTS:Thirty-six events/167 patient-weeks (21.6%) and 54 events/161 patient-weeks (33.5%) of symptomatic mucositis were observed in VE and placebo groups, respectively (p =.038). VE reduced the risk by 36%. Subjective data at the end of the treatment revealed that VE decreased pain grades 2 to 3 during RT (3 of 28 patients vs 14 of 26 patients, p =.0001). No significant influence was detected in survival. CONCLUSION: VE decreased the incidence of symptomatic oral radio-induced mucositis in patients with cancer of the oropharynx and oral cavity. Copyright 2004 Wiley Periodicals, Inc.
RCT Entities:
BACKGROUND: the study was designed to test whether vitamin E (VE) provides oral mucosal protection in patients with irradiated cancers of the head and neck. METHODS: Fifty-four patients with cancer of the oral cavity and oropharynx were randomly assigned to rinse the oral cavity in an oil solution containing either VE or placebo before every conventional fraction of 2 Gy and again 8 to 12 hours later during the 5 to 7 weeks of radiotherapy (RT). RESULTS: Thirty-six events/167 patient-weeks (21.6%) and 54 events/161 patient-weeks (33.5%) of symptomatic mucositis were observed in VE and placebo groups, respectively (p =.038). VE reduced the risk by 36%. Subjective data at the end of the treatment revealed that VE decreased pain grades 2 to 3 during RT (3 of 28 patients vs 14 of 26 patients, p =.0001). No significant influence was detected in survival. CONCLUSION: VE decreased the incidence of symptomatic oral radio-induced mucositis in patients with cancer of the oropharynx and oral cavity. Copyright 2004 Wiley Periodicals, Inc.
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