Double-blind, randomized pilot study of bioadhesive chlorhexidine gel in the prevention and treatment of mucositis induced by chemoradiotherapy of head and neck cancer

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Abstract

Background: to evaluate, in an initial way, the effectiveness of<br />bioadhesive chlorhexidine gel 0.2% versus placebo as a preventive and<br />therapeutic intervention of oral mucositis induced by radiation therapy<br />and chemotherapy in patients diagnosed with head and neck cancer treated<br />with chemoradiotherapy.<br />Material and Methods: In this pilot study, 7 patients (range of age:<br />18-65), having histological documented diagnosis of squamous carcinoma<br />on the head and neck region in stage III and IV, and receiving combined<br />radiation treatment and chemotherapy (cisplatin 100 mg/m(2) IV on days<br />1, 22, and 43 of irradiation) were studied. Simultaneously, a topical<br />application was performed with bioadhesive chlorhexidine gel 0.2% in<br />the study group, and the placebo gel for the control group in 5<br />applications per day, from the time of initiation of cancer treatment to<br />2 weeks after completion of chemo-radiotherapy treatment (11 weeks of<br />follow-up). The gradation of mucositis, pain, analgesic consumption,<br />infectious complications, and treatment tolerance was measured.<br />Results: After 7 patients completed the protocol, any differences were<br />observed between groups in an interval analysis. Mucositis, pain, and<br />tolerance was similar in both groups.<br />Conclusions: Our results must be interpreted with caution due to the<br />reduced sample size, but the use of bioadhesive chlorhexidine gel 0.2%<br />didn't contribute clinical improvement to the oral mucositis induced by<br />radiation therapy and chemotherapy.

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Diaz-Sanchez, R. M., Pachón-Ibáñez, J., Marín-Conde, F., Rodríguez-Caballero, Á., Gutierrez-Perez, J. L., & Torres-Lagares, D. (2015). Double-blind, randomized pilot study of bioadhesive chlorhexidine gel in the prevention and treatment of mucositis induced by chemoradiotherapy of head and neck cancer. Medicina Oral, Patologia Oral y Cirugia Bucal, 20(3), e378–e385. https://doi.org/10.4317/medoral.20338

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