Abstract 939P
Background
Most of the patients with head and neck cancer who undergo radiotherapy experience some degrees of mucositis. Silymarin is a polyphenolic flavonoid that exhibits strong antioxidant and anti-inflammatory activities but has low oral bioavailability. In this research, we evaluated the effect of nano-formulation of silymarin on prevention of radiotherapy induced mucositis in patients with head and neck cancer.
Methods
Thirty-one patients who fulfilled the inclusion criteria randomly assigned to medicine (n=16) or placebo (n=15) group and received 5 ml nano-silymarin solution (70 mg/5 ml) or placebo solution three times daily for 6 weeks started from the first day of radiotherapy. European Organization for Research and Treatment of Cancer (EORTC) mucositis grading scores were recorded at baseline and weekly during 6 weeks of radiotherapy.
Results
The median EORTC scores were not significantly different between silymarin and placebo groups at the end of the sixth week (p>0.05). Moreover, the scores increased significantly in both groups during radiotherapy. However, after 4weeks of treatment with silymarin, the scores had a non-significant decreasing trend in contrast to placebo group.
Conclusions
It seems that increasing the duration of treatment and modification of nano-formulation could improve its efficacy in prevention of radiotherapy induced mucositis.
Clinical trial identification
IRCT2015050622132N1.
Editorial acknowledgement
Legal entity responsible for the study
Mashhad University of Medical Sciences, Mashhad, Iran.
Funding
Mashhad University of Medical Sciences, Mashhad, Iran.
Disclosure
All authors have declared no conflicts of interest.