BACKGROUND:Oral mucositis is a frequent complication of radiochemotherapy. The origin of radiation-induced mucosa lesions is of iatrogenic nature although further development of mucositis is essentially influenced by infection. It can be assumed that disinfection measures should decrease the severity of mucositis induced by radiochemotherapy. Therefore, in a prospective randomised study the efficacy of prophylactic oral rinsing with a disinfection agent was investigated. PATIENTS AND METHOD: An open, randomised, prospective comparative trial was conducted with 40 patients undergoing radiochemotherapy of head and neck region due to malignant disease. The treatment scheme consisted of irradiation to tumor region and adjacent lymph nodes with a total dose of 71.3 Gy and simultaneous chemotherapy with carboplatin (60 mg/m2) on days 1 to 5 and 29 to 34. In all patients, a prophylaxis of mucositis with nystatine, rutosides, panthenol and immunoglobulin was undertaken. In addition, 20 patients rinsed oral cavity 4 times daily with povidone-iodine-solution, the comparative group rinsed with sterile water. Clinical examination of the oral mucosa was performed weekly. Onset, grading and duration of mucositis were used as main variables. RESULTS: Clinically manifested oral mucositis was observed in 14 patients of the iodine group (mean grading: 1.0) and all 20 patients of the control group (mean grading: 3.0). Total duration (mean) of clinically observed mucositis was 2.75 weeks in treatment patients and 9.25 in control patients. Median AUC (area under curve for grade vs duration) was 2.5 in iodine rinsing patients and 15.75 in control patients. All differences found between the 2 groups were statistically significant. Increased iodine incorporation was not observed. A pathological increase of thyroid hormone levels in the iodine group was not found. CONCLUSIONS: The gained results indicate that incidence, severity and duration of radiochemotherapy-induced mucositis can be significantly reduced by oral rinsing with povidone-iodine performed additionally to the standard prophylaxis scheme.
RCT Entities:
BACKGROUND:Oral mucositis is a frequent complication of radiochemotherapy. The origin of radiation-induced mucosa lesions is of iatrogenic nature although further development of mucositis is essentially influenced by infection. It can be assumed that disinfection measures should decrease the severity of mucositis induced by radiochemotherapy. Therefore, in a prospective randomised study the efficacy of prophylactic oral rinsing with a disinfection agent was investigated. PATIENTS AND METHOD: An open, randomised, prospective comparative trial was conducted with 40 patients undergoing radiochemotherapy of head and neck region due to malignant disease. The treatment scheme consisted of irradiation to tumor region and adjacent lymph nodes with a total dose of 71.3 Gy and simultaneous chemotherapy with carboplatin (60 mg/m2) on days 1 to 5 and 29 to 34. In all patients, a prophylaxis of mucositis with nystatine, rutosides, panthenol and immunoglobulin was undertaken. In addition, 20 patients rinsed oral cavity 4 times daily with povidone-iodine-solution, the comparative group rinsed with sterile water. Clinical examination of the oral mucosa was performed weekly. Onset, grading and duration of mucositis were used as main variables. RESULTS: Clinically manifested oral mucositis was observed in 14 patients of the iodine group (mean grading: 1.0) and all 20 patients of the control group (mean grading: 3.0). Total duration (mean) of clinically observed mucositis was 2.75 weeks in treatment patients and 9.25 in control patients. Median AUC (area under curve for grade vs duration) was 2.5 in iodine rinsing patients and 15.75 in control patients. All differences found between the 2 groups were statistically significant. Increased iodine incorporation was not observed. A pathological increase of thyroid hormone levels in the iodine group was not found. CONCLUSIONS: The gained results indicate that incidence, severity and duration of radiochemotherapy-induced mucositis can be significantly reduced by oral rinsing with povidone-iodine performed additionally to the standard prophylaxis scheme.
Authors: Y Tsuzura; I Okabe; I Shimono; M Kamimura; T Kamezawa; M Kitahara; N Iwashita; H Hashiguchi; C Izumoto; Y Fukuyoshi Journal: Gan To Kagaku Ryoho Date: 1992-06
Authors: L P Samaranayake; A G Robertson; T W MacFarlane; I P Hunter; G MacFarlane; D S Soutar; M M Ferguson Journal: Clin Radiol Date: 1988-05 Impact factor: 2.350
Authors: Helen V Worthington; Jan E Clarkson; Gemma Bryan; Susan Furness; Anne-Marie Glenny; Anne Littlewood; Martin G McCabe; Stefan Meyer; Tasneem Khalid Journal: Cochrane Database Syst Rev Date: 2011-04-13