Original Article

Supportive Care in Cancer

, Volume 21, Issue 3, pp 827-834

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

  • D. PawarAffiliated withDrug Research Laboratory
  • , R. S. NeveAffiliated withGokhale Hospital and Ruby Hall Clinic
  • , S. KalganeAffiliated withGokhale Hospital and Ruby Hall Clinic
  • , A. RivaAffiliated withScientific Department, Indena S.p.A.
  • , E. BombardelliAffiliated withScientific Department, Indena S.p.A.
  • , M. RonchiAffiliated withScientific Department, Indena S.p.A.
  • , G. PetrangoliniAffiliated withScientific Department, Indena S.p.A. Email author 
  • , P. MorazzoniAffiliated withScientific Department, Indena S.p.A.

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Abstract

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 < 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.

Keywords

SAMITAL® Oral mucositis Radiotherapy Chemotherapy Head and neck cancer