title: 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.
abstract: OBJECTIVE
  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 < 0.05 versus baseline) reduced from day 31 until the end of treatment in patients treated with SAMITAL® (n = 20). No significant improvement was observed in the placebo group (n = 10). Pain reduction was significant from day 4 till end of treatment with SAMITAL® and from days 7 to 21 in placebo patients. SAMITAL® also significantly improved quality of life, as shown by improvements in scores for relevant daily activities including eating, drinking and sleeping. All SAMITAL® patients completed the treatment period, but no placebo recipients completed treatment. No severe adverse events were observed with SAMITAL®, and systemic absorption of relevant active ingredients was undetectable.
  
  
  CONCLUSIONS
  SAMITAL® significantly decreased the severity of chemo/radiotherapy-induced OM in patients with head and neck cancer, with no treatment-related adverse events. Pain relief lasted through the treatment period, and improvements in quality of life were reflected by the significant benefits of SAMITAL® on activities like drinking, eating and speaking.
authors.affiliation: Drug Research Laboratory, Mumbai, India.
authors.forename: D
authors.initials: D
authors.lastname: Pawar
authors.forename: R S
authors.initials: RS
authors.lastname: Neve
authors.forename: S
authors.initials: S
authors.lastname: Kalgane
authors.forename: A
authors.initials: A
authors.lastname: Riva
authors.forename: E
authors.initials: E
authors.lastname: Bombardelli
authors.forename: M
authors.initials: M
authors.lastname: Ronchi
authors.forename: G
authors.initials: G
authors.lastname: Petrangolini
authors.forename: P
authors.initials: P
authors.lastname: Morazzoni
mesh_terms: D000328:Adult; D000368:Aged; D059248:Chemoradiotherapy / Q000009:adverse effects* / Q000379:methods; D005260:Female; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts; C580632:samital