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Role of benzydamine hydrochloride in the prevention of oral mucositis in head and neck cancer patients treated with radiotherapy (>50 Gy) with or without chemotherapy.
Support Care Cancer. 2017 05; 25(5):1439-1443.SC

Abstract

PURPOSE

Benzydamine is recommended for prophylaxis of oral mucositis (OM) in head and neck cancer (HNC) patients for radiation doses (<50 Gy). This study evaluates role of benzydamine for higher radiation doses (>50 Gy) with or without chemotherapy.

METHODS

One hundred twenty patients of HNC with planned radiation doses of ≥60 Gy were randomized to group A (control radiotherapy alone), group B (study radiotherapy alone), group C (control chemoradiotherapy), or to group D (study chemoradiotherapy). Groups A and C were advised saline mouth rinses, and in groups B and D, additional benzydamine rinses (0.15%) were advised. Mucositis grading was done with both WHO (WHO-M) and CTCAE (CTC-M) version 4.0 (common terminology criteria for adverse events) weekly.

RESULTS

Patient characteristics are presented in the table. Patients in group B had lesser grade 3 WHO-M and CTC-M as compared to group A, 62.1 vs. 36.4% (p = 0.038) and 51.7 vs. 27.3% (p = 0.043), respectively. The rates of Ryle's tube feeding (RTF), intravenous fluid supplementation (IVF), and hospitalization were also lesser in group B as compared to A, 34.5 vs. 21.2% (p = 0.18), 27.6 vs. 9.1% (p = 0.06), and 6.9 vs. 0% (p = 0.21), respectively. WHO-M and CTC-M in groups C and D were not statistically different, 64.3 vs. 43.3% (p = 0.091) and 53.6% vs. 43.3% (p = 0.30), respectively. The rates of RTF, IVF, and hospitalization were all lesser but p > 0.05.

CONCLUSION

Benzydamine significantly reduces OM even at doses >50 Gy in HNC patients. Its role in patients receiving concurrent chemotherapy further needs to be evaluated.

Authors+Show Affiliations

Department of Radiation Oncology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow, 226010, India. drmadhup1@rediffmail.com.Department of Radiation Oncology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow, 226010, India.Department of Radiotherapy, Government Medical College, Haldwani, India.Department of Radiation Oncology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow, 226010, India.Department of Radiotherapy, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.Department of Radiotherapy, Medanta The Medicity, New Delhi, India.Department of Radiotherapy, Batra Hospital and Medical Research Centre, New Delhi, India.Department of Radiotherapy, King George's Medical College, Lucknow, India.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27987094

Citation

Rastogi, Madhup, et al. "Role of Benzydamine Hydrochloride in the Prevention of Oral Mucositis in Head and Neck Cancer Patients Treated With Radiotherapy (>50 Gy) With or Without Chemotherapy." Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer, vol. 25, no. 5, 2017, pp. 1439-1443.
Rastogi M, Khurana R, Revannasiddaiah S, et al. Role of benzydamine hydrochloride in the prevention of oral mucositis in head and neck cancer patients treated with radiotherapy (>50 Gy) with or without chemotherapy. Support Care Cancer. 2017;25(5):1439-1443.
Rastogi, M., Khurana, R., Revannasiddaiah, S., Jaiswal, I., Nanda, S. S., Gupta, P., Chufal, K. S., & Bhatt, M. L. (2017). Role of benzydamine hydrochloride in the prevention of oral mucositis in head and neck cancer patients treated with radiotherapy (>50 Gy) with or without chemotherapy. Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer, 25(5), 1439-1443. https://doi.org/10.1007/s00520-016-3548-9
Rastogi M, et al. Role of Benzydamine Hydrochloride in the Prevention of Oral Mucositis in Head and Neck Cancer Patients Treated With Radiotherapy (>50 Gy) With or Without Chemotherapy. Support Care Cancer. 2017;25(5):1439-1443. PubMed PMID: 27987094.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Role of benzydamine hydrochloride in the prevention of oral mucositis in head and neck cancer patients treated with radiotherapy (>50 Gy) with or without chemotherapy. AU - Rastogi,Madhup, AU - Khurana,Rohini, AU - Revannasiddaiah,Swaroop, AU - Jaiswal,Isha, AU - Nanda,Sambit S, AU - Gupta,Pooja, AU - Chufal,Kundan S, AU - Bhatt,M L, Y1 - 2016/12/16/ PY - 2016/09/30/received PY - 2016/12/12/accepted PY - 2016/12/18/pubmed PY - 2017/10/13/medline PY - 2016/12/18/entrez KW - Benzydamine KW - Chemotherapy KW - Concurrent KW - Radiotherapy SP - 1439 EP - 1443 JF - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer JO - Support Care Cancer VL - 25 IS - 5 N2 - PURPOSE: Benzydamine is recommended for prophylaxis of oral mucositis (OM) in head and neck cancer (HNC) patients for radiation doses (<50 Gy). This study evaluates role of benzydamine for higher radiation doses (>50 Gy) with or without chemotherapy. METHODS: One hundred twenty patients of HNC with planned radiation doses of ≥60 Gy were randomized to group A (control radiotherapy alone), group B (study radiotherapy alone), group C (control chemoradiotherapy), or to group D (study chemoradiotherapy). Groups A and C were advised saline mouth rinses, and in groups B and D, additional benzydamine rinses (0.15%) were advised. Mucositis grading was done with both WHO (WHO-M) and CTCAE (CTC-M) version 4.0 (common terminology criteria for adverse events) weekly. RESULTS: Patient characteristics are presented in the table. Patients in group B had lesser grade 3 WHO-M and CTC-M as compared to group A, 62.1 vs. 36.4% (p = 0.038) and 51.7 vs. 27.3% (p = 0.043), respectively. The rates of Ryle's tube feeding (RTF), intravenous fluid supplementation (IVF), and hospitalization were also lesser in group B as compared to A, 34.5 vs. 21.2% (p = 0.18), 27.6 vs. 9.1% (p = 0.06), and 6.9 vs. 0% (p = 0.21), respectively. WHO-M and CTC-M in groups C and D were not statistically different, 64.3 vs. 43.3% (p = 0.091) and 53.6% vs. 43.3% (p = 0.30), respectively. The rates of RTF, IVF, and hospitalization were all lesser but p > 0.05. CONCLUSION: Benzydamine significantly reduces OM even at doses >50 Gy in HNC patients. Its role in patients receiving concurrent chemotherapy further needs to be evaluated. SN - 1433-7339 UR - https://www.unboundmedicine.com/medline/citation/27987094/Role_of_benzydamine_hydrochloride_in_the_prevention_of_oral_mucositis_in_head_and_neck_cancer_patients_treated_with_radiotherapy__>50_Gy__with_or_without_chemotherapy_ L2 - https://dx.doi.org/10.1007/s00520-016-3548-9 DB - PRIME DP - Unbound Medicine ER -