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. Pawar
  • R. S. Neve
  • S. Kalgane
  • A. Riva
  • E. Bombardelli
  • M. Ronchi
  • G. Petrangolini
  • P. Morazzoni
Original Article

DOI: 10.1007/s00520-012-1586-5

Cite this article as:
Pawar, D., Neve, R.S., Kalgane, S. et al. Support Care Cancer (2013) 21: 827. doi:10.1007/s00520-012-1586-5

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 mucositisRadiotherapyChemotherapyHead and neck cancer

Copyright information

© Springer-Verlag 2012

Authors and Affiliations

  • D. Pawar
    • 1
  • R. S. Neve
    • 2
  • S. Kalgane
    • 2
  • A. Riva
    • 3
  • E. Bombardelli
    • 3
  • M. Ronchi
    • 3
  • G. Petrangolini
    • 3
  • P. Morazzoni
    • 3
  1. 1.Drug Research LaboratoryMumbaiIndia
  2. 2.Gokhale Hospital and Ruby Hall ClinicPuneIndia
  3. 3.Scientific DepartmentIndena S.p.A.MilanItaly