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Randomized control trial of benzydamine HCl versus sodium bicarbonate for prophylaxis of concurrent chemoradiation-induced oral mucositis.
Support Care Cancer. 2018 Mar; 26(3):879-886.SC

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-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+Show Affiliations

Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. imjai@hotmail.com. Northern Thai Research Group of Therapeutic Radiology and Oncology (NTRG-TRO), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. imjai@hotmail.com. Chiang Mai Cancer Registry, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. imjai@hotmail.com.Division of Radiation Oncology, Udornthani Cancer Hospital, Udon Thani, Thailand.Division of Radiation Oncology, Department of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.Radiation Oncology Unit, Department of Radiology, Faculty of Medicine, Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand.Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.Division of Radiation Oncology, Department of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.Division of Radiation Oncology, Maharaj Nakornratchasima Hospital, Nakornratchasima, Thailand.Division of Radiation Oncology, Udornthani Cancer Hospital, Udon Thani, Thailand.Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. Northern Thai Research Group of Therapeutic Radiology and Oncology (NTRG-TRO), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. Chiang Mai Cancer Registry, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.Department of Statistics, Faculty of Science, Chiang Mai University, Chiang Mai, Thailand. Center of Excellence in Bioresources for Agriculture, Industry and Medicine, Chiang Mai University, Chiang Mai, Thailand.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28942587

Citation

Chitapanarux, Imjai, et al. "Randomized Control Trial of Benzydamine HCl Versus Sodium Bicarbonate for Prophylaxis of Concurrent Chemoradiation-induced Oral Mucositis." Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer, vol. 26, no. 3, 2018, pp. 879-886.
Chitapanarux I, Tungkasamit T, Petsuksiri J, et al. Randomized control trial of benzydamine HCl versus sodium bicarbonate for prophylaxis of concurrent chemoradiation-induced oral mucositis. Support Care Cancer. 2018;26(3):879-886.
Chitapanarux, I., Tungkasamit, T., Petsuksiri, J., Kannarunimit, D., Katanyoo, K., Chakkabat, C., Setakornnukul, J., Wongsrita, S., Jirawatwarakul, N., Lertbusayanukul, C., Sripan, P., & Traisathit, P. (2018). Randomized control trial of benzydamine HCl versus sodium bicarbonate for prophylaxis of concurrent chemoradiation-induced oral mucositis. Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer, 26(3), 879-886. https://doi.org/10.1007/s00520-017-3904-4
Chitapanarux I, et al. Randomized Control Trial of Benzydamine HCl Versus Sodium Bicarbonate for Prophylaxis of Concurrent Chemoradiation-induced Oral Mucositis. Support Care Cancer. 2018;26(3):879-886. PubMed PMID: 28942587.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized control trial of benzydamine HCl versus sodium bicarbonate for prophylaxis of concurrent chemoradiation-induced oral mucositis. AU - Chitapanarux,Imjai, AU - Tungkasamit,Tharatorn, AU - Petsuksiri,Janjira, AU - Kannarunimit,Danita, AU - Katanyoo,Kanyarat, AU - Chakkabat,Chakkapong, AU - Setakornnukul,Jiraporn, AU - Wongsrita,Somying, AU - Jirawatwarakul,Naruemon, AU - Lertbusayanukul,Chawalit, AU - Sripan,Patumrat, AU - Traisathit,Patrinee, Y1 - 2017/09/23/ PY - 2017/06/13/received PY - 2017/09/18/accepted PY - 2017/9/25/pubmed PY - 2019/1/5/medline PY - 2017/9/25/entrez KW - Benzydamine HCl KW - Concurrent chemoradiation KW - Mucositis KW - Sodium bicarbonate SP - 879 EP - 886 JF - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer JO - Support Care Cancer VL - 26 IS - 3 N2 - 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-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. SN - 1433-7339 UR - https://www.unboundmedicine.com/medline/citation/28942587/Randomized_control_trial_of_benzydamine_HCl_versus_sodium_bicarbonate_for_prophylaxis_of_concurrent_chemoradiation_induced_oral_mucositis_ L2 - https://dx.doi.org/10.1007/s00520-017-3904-4 DB - PRIME DP - Unbound Medicine ER -