SAMITAL® improves chemo/radiotherapy-induced oral mucositis in patients with head and neck cancer: results of a randomized, placebo-controlled, single-blind Phase II study

• Published in: Supportive care in cancer 2013-03, Vol.21 (3), p.827-834
• Main Authors: Pawar, D., Neve, R. S., Kalgane, S., Riva, A., Bombardelli, E., Ronchi, M., Petrangolini, G., Morazzoni, P.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Care and treatment; Chemoradiotherapy - adverse effects; Chemoradiotherapy - methods; Clinical trials; Female; Head and neck cancer; Head and Neck Neoplasms - therapy; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Nursing; Nursing Research; Oncology; Original Article; Pain - drug therapy; Pain - etiology; Pain Medicine; Plant Extracts - adverse effects; Plant Extracts - therapeutic use; Quality of Life; Rehabilitation Medicine; Severity of Illness Index; Single-Blind Method; Stomatitis; Stomatitis - drug therapy; Stomatitis - etiology; Stomatitis - pathology; Treatment Outcome
• ISSN: 0941-4355; 1433-7339
• DOI: 10.1007/s00520-012-1586-5

Purpose This randomised, placebo-controlled single-blind trial investigated the safety and efficacy of SAMITAL®, a formulation of highly standardised botanical extracts, in the treatment of chemo/radiotherapy-induced oral mucositis (OM) in patients with head and neck cancer. Methods Patients received SAMITAL® or placebo four times daily for up to 50 days during scheduled chemo/radiotherapy. Severity of OM was monitored according to a modified WHO severity scale, and pain and quality-of-life assessments were based on the effect of symptoms of OM on relevant daily activities, according to a visual analogue scale. Results Mean scores for the severity of OM were significantly ( p