Skip to main content
OpenTrials
Completed

NCT Number: NCT02075749

Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Omid ( or Sayyed-O-Shohada) Hospital

Isfahan, 8675446355, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triamcinolone Acetonide

Drug

Other names: made in Germany (Merck)

licorice mucoadhesive films

Drug

30 patients received licorice mucoadhesive films

Other names: AFTOGEL Patch

Primary outcomes

  1. pain score

    Time frame: 4 weeks

    at the end of each consecutive week the pain score was recorded.

Secondary outcomes

  1. mucositis grade

    Time frame: 4 weeks

    the grading of mucositis was assessed and recorded at the end of each week.

Other outcomes

  1. quality of life

    Time frame: 4 weeks

    patient's satisfaction and ability to perform social activity were assessed at the end of trial.

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Comparison of Triamcinolone Acetonide Mucoadhesive Film With Liquorice Mucoadhesive Film On Radiotherapy-Induced Oral Mucositis: A Randomized Double-Blinded Clinical Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 3, 2014
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.