Clinical trial NCT02075749: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mucositis
Keywords: irradiation
mucositis
triamcinolone acetonide
licorice
mucoadhesive film
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: pain score
timeFrame: 4 weeks
Secondary outcomes:
measure: mucositis grade
timeFrame: 4 weeks
Other outcomes:
measure: quality of life
timeFrame: 4 weeks
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Omid ( or Sayyed-O-Shohada) Hospital
Study officials:
References: