Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films

Phase 1

Completed

• Conditions: Mucositis
• Interventions: Drug: licorice mucoadhesive films; Drug: Triamcinolone Acetonide

• Registration Number: NCT02075749
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-02-27
• Study First Posted: 2014-03-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• over 18 years of age
• men and nonpregnant women
• women of childbearing age who were non-pregnant by pregnancy test and and using medically prescribed contraceptive
• no previous radiation therapy applied in the head and neck
• medically fit for a course of radical radiotherapy
• an ability to remain in the study for its entire duration

Exclusion Criteria

• pregnant women
• women of childbearing potential in whom medically prescribed birth control was not used
• concurrent chemotherapy
• history of heavy alcohol or drug abuse judged to be important by the investigator - concomitant therapy with an investigational drug, or cancer chemo therapeutics or immunosuppressive medications
• sensitivity or intolerance to triamcinolone or licorice, lactose or similar formulations
• inability to provide informed consent
• actively bleeding gastric ulcer, severe esophageal reflux
• major surgery, trauma or burns in the preceding 4 weeks
• clinically significant hepatic, neurologic, endocrine, or other systemic disease-making implementation of the protocol or results difficult.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Licorice	licorice mucoadhesive films	30 patients received licorice mucoadhesive films
triamcinolone acetonide mucoadhesive	Triamcinolone Acetonide	30 patients received triamcinolone acetonide mucoadhesive films

Primary Outcome Measures

Name	Time	Method
pain score	4 weeks	at the end of each consecutive week the pain score was recorded.

Secondary Outcome Measures

Name	Time	Method
mucositis grade	4 weeks	the grading of mucositis was assessed and recorded at the end of each week.

Trial Locations

Locations (1)

Omid ( or Sayyed-O-Shohada) Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of