371P - Effect of oral silymarin administration on prevention of radiotherapy induced mucositis: A randomized, double-blinded, placebo-controlled clinical...

Date 17 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Complications of Treatment
Head and Neck Cancers
Surgery and/or Radiotherapy of Cancer
Presenter Sare Hosseini
Citation Annals of Oncology (2016) 27 (suppl_9): ix112-ix122. 10.1093/annonc/mdw587
Authors S. Hosseini1, S. Elyasi2, M.R. Niazi Moghadam3, S.A. Aledavood1, G. Karimi4
  • 1Clinical Oncology, Mashhad University of Medical Sciences-Omid Hospital Cancer Research Center, 9176613775 - Mashhad/IR
  • 2Clinical Pharmacy, Mashhad University of Medical Sciences, 0000000000 - Mashhad/IR
  • 3Department Of Clinical Pharmacy, Mashhad University of Medical Sciences, 0000000000 - Mashhad/IR
  • 4Pharmaceutical Research Center, Mashhad University of Medical Sciences, 0000000000 - Mashhad/IR

Abstract

Background

Mucositis is a frequent severe complication of radiation therapy in patients with head and neck cancer. Silymarin is a polyphenolic flavonoid extracted from the milk thistle that exhibits a strong antioxidant and anti-inflammatory activities. In this study, we evaluated silymarin efficacy in prevention of radiotherapy-induced mucositis in patients with head and neck cancer as the first in human study.

Methods

During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of oral silymarin 420 mg daily in three divided doses starting at the first day of radiotherapy session and continuing for six weeks on oral mucositis occurrence were assessed. Twenty-seven patients fulfilled the inclusion criteria assigned to the silymarin or placebo group. World Health Organization (WHO) and National Cancer Institute-Common Terminology Criteria (NCI-CTC) oral mucositis grading scale scores were recorded at baseline and weekly during the 6 weeks.

Results

The median WHO and NCI-CTC scores was significantly lower in the silymarin group at the end of the first to sixth week (P 

Conclusions

Prophylactic administration of conventional form of silymarin tablets could reduce radiotherapy-induced mucositis in patients with head and neck cancer.

Clinical trial indentification

Legal entity responsible for the study

N/A

Funding

Research Council of Mashhad University of Medical Sciences and to Goldaroo Company

Disclosure

All authors have declared no conflicts of interest.