Table 2.

Clinical trial and reviews characteristic and results

Authors/year/number of patients	Type of research	Type of cancer	Mucosal areas assessed/particular exclusions	RT dose, Gy	KPS/ECOG	Benzydamine administered	Effect of Benzydamine
Epstein et al./2001/patients: 160	Multicenter/randomized/double-blind/Placebo-controlled	Head-neck carcinoma/ oral, lip, pharynx: 78% larynx, saliv. glands, others: 22%	All, including hard palate, gingivae, dorsum of tongue. Candidiasis was diagnosed	50 Gy	>80%	Prior to start RT to 2 weeks after completion	Significant reduction of oral mucositis and oral analgesics
Cheng et al./2006/ patients: 14	Prospective/Randomized/Double-blind against Chlorhexidine	Nasopharyngeal/non-nasopharyngeal, including saliv. glands, etc.	Not reported. Mucosal infections not assessed	66 to 68 Gy	-	From 1st day to 2 weeks after completion	Trend of reduction of oral mucositis, pain and dysphagia
Kazemian et al./2009/patients: 81	Prospective/randomized/double-blind/placebo-controlled	Head-neck carcinoma, not otherwise specified	Hard palate, oral tongue, oropharynx, buccal mucosa, floor of mouth. Nystatin prescribed when mucositis > grade 2	61.69 Gy, mean	>70%	A day from start to end of RT	Significant reduction of oral mucositis
Roopashri et al./2011/patients: 100	Prospective/placebo-controlled against chlorhexidine and povidone iodine	Head-neck carcinoma, not otherwise specified	Not specifically defined/excluded ages >30y and over 79y, with bacterial/fungal infections, mucosal changes, dryness, receiving antibiotics, analgesics	66 Gy	-	After 2 weeks of start of RT at onset of mucositis	Benzydamine more efficient to delay mucositis and reduce intensity of pain
Rastogi et al./2016/patients: 120	Prospective/randomized/controlled RT or ChemoRT groups against saline	Head-neck carcinoma, not otherwise specified	Not specifically defined/oral infections not assessed	>60 Gy	>70	Not clear	Significant reduction of oral mucositis in RT
Systematic reviews on benzydamine effect on oral mucositis
Nicolatou-Galitis et al./2013/MASCC/ISOO systematic review			Benzydamine is recommended for prevention of oral mucositis in H/N RT receiving moderate-dose radiation therapy up to 50 Gy, without concomitant Chemo
Ariyawardana et al./2019/ MASCC/ISOO systematic review			Benzydamine mouthwash is recommended for prevention of oral mucositis in H/N RT receiving moderate-dose radiation therapy up to 50 Gy Benzydamine mouthwash is suggested for the prevention of oral mucositis in patients with H/N cancer receiving RT and CHT