Evaluation of the effectiveness of licorice mucoadhesive film and triamcinolone acetonide mucoadhesive film on symptoms of head and neck radiotherapy-induced mucositis in comparison with placebo
Application of Licorice and/or Triamcinolone acetonide muco-adhesive films as complementary medication in addition to standard oral care in neck and head radiotherapy induced oral mucositis
Design
Clinical trial with control group, parallel intervention groups, double blinded, randomized, phase 3 on 90 patients, Simple Random Sampling and random digits table was used for randomization.
Settings and conduct
The site of research: radiation section of Omid hospital in Isfahan.
Blinding process in this research: Double blind
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with radiotherapy induced oral mucositis; age above 18 years; non-pregnant women; patient willingness to remain in the study.
Non-inclusion criteria:
History of drug abuse; simultaneous with another drug; allergy or intolerance to corticosteroids; inability to provide informed consent; high blood pressure; active gastric ulcer; Liver disease; neural disease; Endocrine disorders or other significant systemic diseases that make it difficult to implement the protocols or test the results.
Intervention groups
Intervention group1: group of licorice mucoadhesive, with Aphthogel brand name, in which participants take the drug three times a day after meals and once before sleep on the upper lip mucosal surface during the research.
Intervention group2: group of triamcinolone mucoadhesive in which participants take the drug three times a day after meals and once before sleep on the upper lip mucosal surface during the research.
Control group : group of placebo mucoadhesive, in which participants take the drug three times a day after meals and once before sleep on the upper lip mucosal surface during the research.
Main outcome variables
Oral mucositis grade; Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200303046685N1
Registration date:2020-06-29, 1399/04/09
Registration timing:retrospective
Last update:2020-06-29, 1399/04/09
Update count:0
Registration date
2020-06-29, 1399/04/09
Registrant information
Name
Fahimeh Pakravan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3436 8793
Email address
pakravan@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-11, 1398/09/20
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of licorice mucoadhesive film and triamcinolone acetonide mucoadhesive film on symptoms of head and neck radiotherapy-induced mucositis in comparison with placebo
Public title
Effectiveness of licorice and triamcinolone acetonide muco-adhesive films on mucositis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with radiotherapy induced oral mucositis
Age above 18 years
Non-pregnant women
Patient willingness to remain in the study
Exclusion criteria:
History of drug abuse that interferes with the treatment procedure in the researcher’s point of view
simultaneous treatment with another drug
allergy or intolerance to corticosteroids
inability to provide informed consent
high blood pressure
active gastric ulcer
liver disease, neural disease
Endocrine disorders or other significant systemic diseases that make it difficult to implement the protocols or test the results
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Among patients suffering from oral mucositis induced by head and neck radiotherapy who refereed to Seyed-olshohada hospital in Isfahan, 90 patients who have been examined by supervisor and have met the eligibility criteria, will enter the study and a number will be assigned to every patient. Then they will be divided into two intervention groups and one control group using block randomization (block size=30) through the random allocation service software. For allocation concealment, sealed coded boxes with randomized sequence with the same size and weight will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the participant and the investigator are not aware of the administered medication because of the similarity of the films In appearance, color and smell provided to the participants
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-12-19, 1398/09/28
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.548
Health conditions studied
1
Description of health condition studied
oral mucositis
ICD-10 code
K12.33
ICD-10 code description
Oral mucositis (ulcerative) due to radiation
Primary outcomes
1
Description
Mucositis Grade
Timepoint
At the beginning of the study and at days 7,14 and 21
Method of measurement
WHO mucositis assessment scale
Secondary outcomes
1
Description
Oral pain
Timepoint
At the beginning of the study and at days 7,14 and 21
Method of measurement
VAS ( visual analogue scale)
Intervention groups
1
Description
Intervention group 1: Licorice mucoadhesive film, with Aphthogel brand name, made by Dr Saniee Pharmaceutical Company, locally applied on upper lip mucosa, after each meal and once before sleep, for 15 to 20 minutes.
Category
Treatment - Drugs
2
Description
Intervention group 2: Triamcinilone acetonide mucoadhesive film, with 1mg active ingredient, made by Dr Saniee Pharmaceutical Company, locally applied on upper lip mucosa, after each meal and once before sleep, for 15 to 20 minutes.
Category
Treatment - Drugs
3
Description
Control group: placebo mucoadhesive film with the same formulation as other drugs used in the study but without licorice and triamcinolone, made by Dr Saniee Pharmaceutical Company, locally applied on upper lip mucosa, after each meal and once before sleep, for 15 to 20 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed Al-Shohada hospital in Isfahan
Full name of responsible person
Fahimeh Pakravan
Street address
Soffeh boulvard
City
Isfahan
Province
Isfehan
Postal code
8117891389
Phone
+98 31 3792 5515
Email
pakravan@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
City
Isfshan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3436 8793
Email
pakravan@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fahimeh pakravan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
817473461
Phone
+98 31 3436 8793
Email
pakravan@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fahimeh Pakravan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Oral medicine
Street address
Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
817473461
Phone
+98 31 3792 5515
Email
Pakravan@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fahimeh Pakravan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Oral medicine
Street address
Soffeh boulvard
City
Isfahan
Province
Isfehan
Postal code
817473461
Phone
+98 31 3792 5515
Email
Pakravan@dnt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only information such as main consequence or the like can be shared.
When the data will become available and for how long
Access to the results immediately after publication
To whom data/document is available
Open access
Under which criteria data/document could be used
Access to data is possible only after formal permission from corresponding author
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document