Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films

July 9, 2014 updated by: Mehdi Nasr Isfahani, Isfahan University of Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: triamcinolone acetonide mucoadhesive
30 patients received triamcinolone acetonide mucoadhesive films
Drug: Triamcinolone Acetonide
Other Names:
  • made in Germany (Merck)
Experimental: Licorice
30 patients received licorice mucoadhesive films
Drug: licorice mucoadhesive films
30 patients received licorice mucoadhesive films
Other Names:
  • AFTOGEL Patch
Placebo Comparator: Mucoadhesive film
30 patients received mucoadhesive films without any drug ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 4 weeks
at the end of each consecutive week the pain score was recorded.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mucositis grade
Time Frame: 4 weeks
the grading of mucositis was assessed and recorded at the end of each week.
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 4 weeks
patient's satisfaction and ability to perform social activity were assessed at the end of trial.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 393009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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