title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.affiliation: Department of Radiation Oncology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow, 226010, India. drmadhup1@rediffmail.com.
authors.forename: Madhup
authors.initials: M
authors.lastname: Rastogi
authors.affiliation: Department of Radiation Oncology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow, 226010, India.
authors.forename: Rohini
authors.initials: R
authors.lastname: Khurana
authors.affiliation: Department of Radiotherapy, Government Medical College, Haldwani, India.
authors.forename: Swaroop
authors.initials: S
authors.lastname: Revannasiddaiah
authors.affiliation: Department of Radiation Oncology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow, 226010, India.
authors.forename: Isha
authors.initials: I
authors.lastname: Jaiswal
authors.affiliation: Department of Radiotherapy, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.
authors.forename: Sambit S
authors.initials: SS
authors.lastname: Nanda
authors.affiliation: Department of Radiotherapy, Medanta The Medicity, New Delhi, India.
authors.forename: Pooja
authors.initials: P
authors.lastname: Gupta
authors.affiliation: Department of Radiotherapy, Batra Hospital and Medical Research Centre, New Delhi, India.
authors.forename: Kundan S
authors.initials: KS
authors.lastname: Chufal
authors.affiliation: Department of Radiotherapy, King George's Medical College, Lucknow, India.
authors.forename: M L
authors.initials: ML
authors.lastname: Bhatt
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001591:Benzydamine / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D004307:Dose-Response Relationship, Radiation; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000627:therapeutic use; D011446:Prospective Studies; D011832:Radiation Injuries / Q000209:etiology / Q000517:prevention & control*; D000077195:Squamous Cell Carcinoma of Head and Neck; D013280:Stomatitis / Q000209:etiology / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D009067:Mouthwashes; D001591:Benzydamine
keywords: Benzydamine; Chemotherapy; Concurrent; Radiotherapy