- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02075749
Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films
Comparison of Triamcinolone Acetonide Mucoadhesive Film With Liquorice Mucoadhesive Film On Radiotherapy-Induced Oral Mucositis: A Randomized Double-Blinded Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Isfahan, Iran, Islamic Republic of, 8675446355
- Omid ( or Sayyed-O-Shohada) Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: triamcinolone acetonide mucoadhesive
30 patients received triamcinolone acetonide mucoadhesive films
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Other Names:
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Experimental: Licorice
30 patients received licorice mucoadhesive films
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30 patients received licorice mucoadhesive films
Other Names:
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Placebo Comparator: Mucoadhesive film
30 patients received mucoadhesive films without any drug ingredients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain score
Time Frame: 4 weeks
|
at the end of each consecutive week the pain score was recorded.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mucositis grade
Time Frame: 4 weeks
|
the grading of mucositis was assessed and recorded at the end of each week.
|
4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of life
Time Frame: 4 weeks
|
patient's satisfaction and ability to perform social activity were assessed at the end of trial.
|
4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Stomatognathic Diseases
- Mouth Diseases
- Mucositis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- 393009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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