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Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films

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ClinicalTrials.gov Identifier: NCT02075749
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : July 10, 2014
Information provided by (Responsible Party):
Mehdi Nasr Isfahani, Isfahan University of Medical Sciences

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Mucositis Drug: Triamcinolone Acetonide Drug: licorice mucoadhesive films Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Comparison of Triamcinolone Acetonide Mucoadhesive Film With Liquorice Mucoadhesive Film On Radiotherapy-Induced Oral Mucositis: A Randomized Double-Blinded Clinical Trial
Study Start Date : May 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Active Comparator: triamcinolone acetonide mucoadhesive
30 patients received triamcinolone acetonide mucoadhesive films
Drug: Triamcinolone Acetonide
Other Name: made in Germany (Merck)

Experimental: Licorice
30 patients received licorice mucoadhesive films
Drug: licorice mucoadhesive films
30 patients received licorice mucoadhesive films
Other Name: AFTOGEL Patch

Placebo Comparator: Mucoadhesive film
30 patients received mucoadhesive films without any drug ingredients

Primary Outcome Measures :
  1. pain score [ Time Frame: 4 weeks ]
    at the end of each consecutive week the pain score was recorded.

Secondary Outcome Measures :
  1. mucositis grade [ Time Frame: 4 weeks ]
    the grading of mucositis was assessed and recorded at the end of each week.

Other Outcome Measures:
  1. quality of life [ Time Frame: 4 weeks ]
    patient's satisfaction and ability to perform social activity were assessed at the end of trial.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075749

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Iran, Islamic Republic of
Omid ( or Sayyed-O-Shohada) Hospital
Isfahan, Iran, Islamic Republic of, 8675446355
Sponsors and Collaborators
Isfahan University of Medical Sciences
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Responsible Party: Mehdi Nasr Isfahani, Dr. Nasr, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02075749    
Other Study ID Numbers: 393009
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014
Keywords provided by Mehdi Nasr Isfahani, Isfahan University of Medical Sciences:
triamcinolone acetonide
mucoadhesive film
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action