Imjai Chitapanarux1,2,3, Tharatorn Tungkasamit4, Janjira Petsuksiri5, Danita Kannarunimit6, Kanyarat Katanyoo7, Chakkapong Chakkabat6, Jiraporn Setakornnukul5, Somying Wongsrita8, Naruemon Jirawatwarakul4, Chawalit Lertbusayanukul6, Patumrat Sripan9,10,11, Patrinee Traisathit12,13. 1. Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. imjai@hotmail.com. 2. Northern Thai Research Group of Therapeutic Radiology and Oncology (NTRG-TRO), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. imjai@hotmail.com. 3. Chiang Mai Cancer Registry, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. imjai@hotmail.com. 4. Division of Radiation Oncology, Udornthani Cancer Hospital, Udon Thani, Thailand. 5. Division of Radiation Oncology, Department of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. 6. Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand. 7. Radiation Oncology Unit, Department of Radiology, Faculty of Medicine, Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand. 8. Division of Radiation Oncology, Maharaj Nakornratchasima Hospital, Nakornratchasima, Thailand. 9. Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. 10. Northern Thai Research Group of Therapeutic Radiology and Oncology (NTRG-TRO), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. 11. Chiang Mai Cancer Registry, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. 12. Department of Statistics, Faculty of Science, Chiang Mai University, Chiang Mai, Thailand. 13. Center of Excellence in Bioresources for Agriculture, Industry and Medicine, Chiang Mai University, Chiang Mai, Thailand.
Abstract
PURPOSE: The purpose of the study is to compare the efficacy of benzydamine HCl with sodium bicarbonate in the prevention of concurrent chemoradiation-induced oral mucositis in head and neck cancer patients. METHODS:Sixty locally advanced head and neck cancer patients treated with high-dose radiotherapy concurrently with platinum-based chemotherapy were randomly assigned to receive either benzydamine HCl or sodium bicarbonate from the first day of treatment to 2 weeks after the completion of treatment. The total score for mucositis, based on the Oral Mucositis Assessment Scale (OMAS), was used for the assessment, conducted weekly during the treatment period and at the fourth week of the follow-up. Pain score, all prescribed medications, and tube feeding needs were also recorded and compared. RESULTS: The median of total OMAS score was statistically significant lower in patients who received benzydamine HCl during concurrent chemo-radiotherapy (CCRT) than in those who received sodium bicarbonate, (p value < 0.001). There was no difference in median pain score, (p value = 0.52). Nineteen percent of patients in sodium bicarbonate arm needed oral antifungal agents whereas none in the benzydamine HCl arm required such medications, (p value = 0.06). Tube feeding needs and the compliance of CCRT were not different between the two study arms. CONCLUSIONS: For patients undergoing high-doseradiotherapy concurrently with platinum-based chemotherapy, using benzydamine HCl mouthwash as a preventive approach was superior to basic oral care using sodium bicarbonate mouthwash in terms of reducing the severity of oral mucositis and encouraging trend for the less need of oral antifungal drugs.
RCT Entities:
PURPOSE: The purpose of the study is to compare the efficacy of benzydamine HCl with sodium bicarbonate in the prevention of concurrent chemoradiation-induced oral mucositis in head and neck cancerpatients. METHODS: Sixty locally advanced head and neck cancerpatients treated with high-dose radiotherapy concurrently with platinum-based chemotherapy were randomly assigned to receive either benzydamine HCl or sodium bicarbonate from the first day of treatment to 2 weeks after the completion of treatment. The total score for mucositis, based on the Oral Mucositis Assessment Scale (OMAS), was used for the assessment, conducted weekly during the treatment period and at the fourth week of the follow-up. Pain score, all prescribed medications, and tube feeding needs were also recorded and compared. RESULTS: The median of total OMAS score was statistically significant lower in patients who received benzydamine HCl during concurrent chemo-radiotherapy (CCRT) than in those who received sodium bicarbonate, (p value < 0.001). There was no difference in median pain score, (p value = 0.52). Nineteen percent of patients in sodium bicarbonate arm needed oral antifungal agents whereas none in the benzydamine HCl arm required such medications, (p value = 0.06). Tube feeding needs and the compliance of CCRT were not different between the two study arms. CONCLUSIONS: For patients undergoing high-dose radiotherapy concurrently with platinum-based chemotherapy, using benzydamine HCl mouthwash as a preventive approach was superior to basic oral care using sodium bicarbonate mouthwash in terms of reducing the severity of oral mucositis and encouraging trend for the less need of oral antifungal drugs.
Authors: Jay S Cooper; Thomas F Pajak; Arlene A Forastiere; John Jacobs; Bruce H Campbell; Scott B Saxman; Julie A Kish; Harold E Kim; Anthony J Cmelak; Marvin Rotman; Mitchell Machtay; John F Ensley; K S Clifford Chao; Christopher J Schultz; Nancy Lee; Karen K Fu Journal: N Engl J Med Date: 2004-05-06 Impact factor: 91.245
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Authors: J B Epstein; S Silverman; D A Paggiarino; S Crockett; M M Schubert; N N Senzer; P B Lockhart; M J Gallagher; D E Peterson; F G Leveque Journal: Cancer Date: 2001-08-15 Impact factor: 6.860
Authors: Clifton P Thornton; Mengchi Li; Chakra Budhathoki; Chao Hsing Yeh; Kathy Ruble Journal: Support Care Cancer Date: 2022-04-29 Impact factor: 3.359