Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films

Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075749
• Other study ID #: 393009
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 26, 2014
• Last updated: July 9, 2014
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: July 2014
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mucositis

Intervention

Drug:
• Triamcinolone Acetonide

• licorice mucoadhesive films
30 patients received licorice mucoadhesive films

Locations

Country	Name	City	State
Iran, Islamic Republic of	Omid ( or Sayyed-O-Shohada) Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	quality of life	patient's satisfaction and ability to perform social activity were assessed at the end of trial.	4 weeks	No
Primary	pain score	at the end of each consecutive week the pain score was recorded.	4 weeks	Yes
Secondary	mucositis grade	the grading of mucositis was assessed and recorded at the end of each week.	4 weeks	No