Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films

Study Overview
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Brief Summary
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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.

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

Conditions
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Mucositis

Intervention / Treatment
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* Drug: Triamcinolone Acetonide
* Drug: licorice mucoadhesive films


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: triamcinolone acetonide mucoadhesive<br>30 patients received triamcinolone acetonide mucoadhesive films | Drug: Triamcinolone Acetonide<br> <br> * Other names: made in Germany (Merck);|
| Experimental: Licorice<br>30 patients received licorice mucoadhesive films | Drug: licorice mucoadhesive films<br>* 30 patients received licorice mucoadhesive films<br>* Other names: AFTOGEL Patch;|
| Placebo Comparator: Mucoadhesive film<br>30 patients received mucoadhesive films without any drug ingredients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | 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 | the grading of mucositis was assessed and recorded at the end of each week. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irradiation, mucositis, triamcinolone acetonide, licorice, mucoadhesive film