Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films
Primary Purpose
Mucositis
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Triamcinolone Acetonide
licorice mucoadhesive films
Sponsored by
About this trial
This is an interventional supportive care trial for Mucositis focused on measuring irradiation, mucositis, triamcinolone acetonide, licorice, mucoadhesive film
Eligibility Criteria
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.
Sites / Locations
- Omid ( or Sayyed-O-Shohada) Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
triamcinolone acetonide mucoadhesive
Licorice
Mucoadhesive film
Arm Description
30 patients received triamcinolone acetonide mucoadhesive films
30 patients received licorice mucoadhesive films
30 patients received mucoadhesive films without any drug ingredients
Outcomes
Primary Outcome Measures
pain score
at the end of each consecutive week the pain score was recorded.
Secondary Outcome Measures
mucositis grade
the grading of mucositis was assessed and recorded at the end of each week.
Full Information
NCT ID
NCT02075749
First Posted
February 26, 2014
Last Updated
July 9, 2014
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02075749
Brief Title
Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films
Official Title
Comparison of Triamcinolone Acetonide Mucoadhesive Film With Liquorice Mucoadhesive Film On Radiotherapy-Induced Oral Mucositis: A Randomized Double-Blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis
Keywords
irradiation, mucositis, triamcinolone acetonide, licorice, mucoadhesive film
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
triamcinolone acetonide mucoadhesive
Arm Type
Active Comparator
Arm Description
30 patients received triamcinolone acetonide mucoadhesive films
Arm Title
Licorice
Arm Type
Experimental
Arm Description
30 patients received licorice mucoadhesive films
Arm Title
Mucoadhesive film
Arm Type
Placebo Comparator
Arm Description
30 patients received mucoadhesive films without any drug ingredients
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
made in Germany (Merck)
Intervention Type
Drug
Intervention Name(s)
licorice mucoadhesive films
Other Intervention Name(s)
AFTOGEL Patch
Intervention Description
30 patients received licorice mucoadhesive films
Primary Outcome Measure Information:
Title
pain score
Description
at the end of each consecutive week the pain score was recorded.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
mucositis grade
Description
the grading of mucositis was assessed and recorded at the end of each week.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
quality of life
Description
patient's satisfaction and ability to perform social activity were assessed at the end of trial.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Omid ( or Sayyed-O-Shohada) Hospital
City
Isfahan
ZIP/Postal Code
8675446355
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films
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