Mucositis Clinical Trial
Official title:
Comparison of Triamcinolone Acetonide Mucoadhesive Film With Liquorice Mucoadhesive Film On Radiotherapy-Induced Oral Mucositis: A Randomized Double-Blinded Clinical Trial
Abstract:
Background: Complementary and alternative medicine (CAM) had proven efficacy in pain relief,
correction of nutritional status and improving the performance status. However, lack of
standardization is the major obstacle for any scientific evaluation of any CAM trial.
Mucositis is a major complication of irradiation in head and neck (H&N) tumors, the addition
of chemotherapy to irradiation may enhance this dose limiting problem. Licorice is a strong
demulcent that had been effectively used in treatment of peptic ulcer. The main purpose of
this study was to compare the therapeutic safety and efficacy of T. and L. mucoadhesive
films on oral mucositis in terms of pain control and/or ulcer treatment.
Methods and Materials: the study was a double-blind, randomized prospective trial of two
types of mucoadhesive films in the management of oral mucositis occurred during head and
neck cancer ( HNC ) radiotherapy. oral mucositis was assessed using a quantitative scale
(WHO scales) and symptoms were assessed using visual analogue scales (VAS). 60 patients were
enrolled in the study; there were 30 patients in the Triamcinolone (T) and 30 in the
Licorice (L) group. In the T- group, patients received triamcinolone acetonide mucoadhesive
films containing 1mg of the drug and patients in the L- group received licorice mucoadhesive
films, an herbal agent. Data were collected at baseline, then twice a week for 4 weeks.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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