Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films

Sponsor

Isfahan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02075749

Collaborator

(none)

Enrollment

Location

Arms

9.1

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mucositis	Drug: Triamcinolone Acetonide Drug: licorice mucoadhesive films	Phase 1/Phase 2

Study Design

Study Type:

Interventional

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 1, 2013

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

pain score [4 weeks]
at the end of each consecutive week the pain score was recorded.

Secondary Outcome Measures

mucositis grade [4 weeks]
the grading of mucositis was assessed and recorded at the end of each week.

Other Outcome Measures

quality of life [4 weeks]
patient's satisfaction and ability to perform social activity were assessed at the end of trial.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

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.