Patients will be enrolled from the oncology department of Nemazee Hospital, in Shiraz, Iran. Data are gathered by observation and interview. Patients are examined for oral mucositis and are assessed using the WHO grading on a scale of 0–4. Severity of oral pain is evaluated using a visual analogue scale (VAS) scoring 0–10 . The extension of lesions is also recorded by the number of involved sites. These examinations are performed at three intervals: prior to the start of the study, one and two weeks after treatment.
After examination, the phenytoin mouthwash and mucoadhesive tablet which are prepared by the faculty of Shiraz pharmacy; is delivered to the patient.
Participants/Inclusion and exclusion criteria
The study population consist of patients undergoing chemotherapy process, due to various types of malignancies
Intervention groups
Patients in group A will be instructed to rinse (gargle) 10 ml of the solution for one minute, three times a day (to distribute evenly to all parts of the oral tissues), and then spit. For patients in group B, two tablets should be attached inside the cheek until they are dissolved.
Main outcome variables
the grade of oral mucositis, the number of oral lesions, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130521013406N5
Registration date:2019-07-07, 1398/04/16
Registration timing:retrospective
Last update:2019-07-07, 1398/04/16
Update count:0
Registration date
2019-07-07, 1398/04/16
Registrant information
Name
Fahimeh Rezazadeh
Name of organization / entity
Dental school of shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 1628 9917
Email address
rezazadehf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Phenytoin mucoadhesive tablet versus mouthwash on chemotherapy induced oral mucositis
Public title
Phenytoin Mucoadehesive Tablet versus Mouthwash in treatment of Oral Mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients underwent chemotherapy process, due to various types of malignancies, without concurrent radiotherapy
mucositis grade 2 or 3 (WHO criteria)
prognosis for at least 6 months
signing the consent form
Exclusion criteria:
Patients with mucositis of grade 1 or 4
sign of causing side effects (such as sensitivity to phenytoin)
lack of patient cooperation or trend to complete the treatment process
systemic diseases with oral mucositis (such as connective tissue diseases and Sjogren syndrome)or interfering with healing process of tissues (such as diabetes)
smoking and alcohol consumption
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
block randomized study
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2014-04-09, 1393/01/20
Ethics committee reference number
8593063
Health conditions studied
1
Description of health condition studied
chemotherapy induced oral mucositis
ICD-10 code
K12.31
ICD-10 code description
Oral mucositis (ulcerative) due to antineoplastic therapy
Primary outcomes
1
Description
grade of oral mucositis and pain
Timepoint
before intervention, 1 and 2 weeks after intervention
Method of measurement
WHO grading and Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: phenytoin mucoadhesive tablet Mucoadhesive tablets are prepared by direct compression method. The ingredients (10 mg sodium phenytoin and the remaining ingredient was HPMC: Chitosan; NaCMC, 25:25:50 w/w %) are weighed accurately and mixed by trituration in a mortar by pestle for 15 minutes. Then all of the ingredients are passed through sieve no. 100. Finally the mixture is compressed to tablet using Korsch single punch compression machine (ERWEKA, German).Each day, two tablets should be attached inside the cheek until they are dissolved and the treatment should be continued until the complete healing of oral lesions or for a maximum of two weeks.
Category
Treatment - Drugs
2
Description
Intervention group: Phenytoin mouthwash Appropriate amount of sodium phenytoin is dissolved in 1 L of distilled water which contain 0.1% Tween 80 and Disodium hydrogen phosphate (2.38 g/L), with adjusted pH on 7.0±0.02 using phosphoric acid. The final concentration of phenytoin mouthwash is 0.333 mg/mL. patients are instructed to rinse (gargle) 10 ml of the solution for one minute, three times a day (to distribute evenly to all parts of the oral tissues), and then spit (to minimize the systemic absorption). They are told to avoid eating during the first hour after treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazee hospital
Full name of responsible person
Fahimeh Rezazadeh
Street address
Namazi square, Zand Ave, Shiraz, Fars
City
Shiraz
Province
Fars
Postal code
71936-13311
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
nemazee_inf@sums.ac.ir
Web page address
http://namazi.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz University of Medical Sciences
City
Sshiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Web page address
https://sums.ac.ir/
Grant name
no grant
Grant code / Reference number
000000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Rezazadeh
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz University of Medical Sciences, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
Rezazadehf@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Rezazadeh
Position
Assisstant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz University of Medical sciences, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
rezazadehf@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Rezazadeh
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
oral medicine department, Shiraz Dental School, Ghasrodasht Ave
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3628 9917
Fax
+98 71 1626 3193
Email
rezazadehf@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available