The purpose of this study is the comparison of effectiveness of mouthwash Benzydamine and combination of Benzydamine-Sucralfate in patients with malignancy undergoing chemotherapy.
The patients with leukemia [acute lymphoid leukemia (ALL) or acute myeloid leukemia (AML)], new cases at the start of chemotherapy are targeted population.
Twenty four patients (twelve patients in each group: six with AML and six with ALL) constitute the sample size.
At the beginning of chemotherapy with coordination of the oncologist the patient is placed in one of two groups, group X (benzydamine) or Y (benzydamine-sucralfate) by nurse (of research team).
At first day, the researcher educates oral hygiene to the patients and then records the condition of their mouth's health with a questionnaire based on the targeted group, then the nurse gives medication and educates the directions of usage to group X and Y.
On the days of 6, 9, 12, and 14 the patients’ mouth will be examined and also the condition of the mouth will be recorded based on the questionnaire and at the end, statistical analysis will be done.
Possess one of hematologic malignancies(ALL or AML) according to the oncologist- similar chemotherapy treatment planning- patients who are at beginning of their chemotherapy courses (new case) and absence of any fungal ,viral or other lesions in the patient's mouth are inclusion criteria.
Appearance of fungal or viral lesions in the patient's mouth or lack of patient cooperation at protocol X or Y are among exclusion criteria.
Mouthwash Benzydamine and combination of Benzydamine-Sucralfate are interventions of the research.
Pain, erythema , ulcer and stomatitis are primary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101311099N1
Registration date:2013-05-18, 1392/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-18, 1392/02/28
Registrant information
Name
Mahrooz Ershadi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences-Yazd
Country
Iran (Islamic Republic of)
Phone
+98 937 326 4731
Email address
drershadi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahid Sadoghi University of Medical Sciences- Yazd
Expected recruitment start date
2012-09-11, 1391/06/21
Expected recruitment end date
2013-04-10, 1392/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Effectiveness of mouthwash Benzydamine and combination of Benzydamine-Sucralfate in patients with malignancy undergoing chemotherapy
Public title
Prevention of chemotherapy-induced stomatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Possess one of hematologic malignancies( acute lymphoid leukemia (ALL) or acute myeloid leukemia (AML) according to the oncologist- similar chemotherapy treatment planning- patients are beginning to chemotherapy (new case)- absence of any fungal,viral or other lesions in the patient's mouth
Exclusion criteria:
appearance of fungal or viral lesions in the patient's mouth- lack of patient cooperation protocol X or Y
Age
From 14 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study is double-blind because:
The labels of medications are peeled so the patient is not aware of the type of drug.
The examiner does not give the drugs to the patients, but also the advisor of project gives the drugs and educates application
of it to the patient. He does not have any role in the examination.
Method of randomization:
Using software to Random Number Generation patients are randomly assigned to one of two groups: X or Y.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Central Organization for Shahid Sadoughi University of Medical Sciences, Bahonar Sq., Yazd
City
Yazd
Postal code
8916978477
Approval date
2012-09-11, 1391/06/21
Ethics committee reference number
83152/1/17/پ
Health conditions studied
1
Description of health condition studied
Chemotherapy-induced mucositis
ICD-10 code
K13.7
ICD-10 code description
Other and unspecified lesions of oral mucosa
Primary outcomes
1
Description
Pain
Timepoint
Day 0(Concurrent with intervention)-days 6,9,12 and 14 after the start of intervention
Method of measurement
VAS scale
2
Description
Erythema
Timepoint
Day 0(Concurrent with intervention)-days 6,9,12 and 14 after the start of intervention
Method of measurement
Square centimeter
3
Description
Grading of stomatitis
Timepoint
Day 0(Concurrent with intervention)-days 6,9,12 and 14 after the start of intervention
Method of measurement
WHO grading
4
Description
Ulcer
Timepoint
Day 0(Concurrent with intervention)-days 6,9,12and 14 after the start of intervention
Method of measurement
Square centimeter
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Mouthwash Benzydamine hydrochloride .15%, produced by Behvazan company-three times a day- after meal 15 ml- rinse and spit out
Category
Prevention
2
Description
Intervention group: Combination of Benzydamine-Sucralfate (mouthwash Benzydamine hydrochloride .15%15ml + powdered tab sucralfate 500 mg)-three times a day after meal -rinse and spit out
sucralfate powder is produced of sucralfate tablets (500 mg) of Soha company
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr. Mohammad Forat Yazdi
Street address
Shahid Dashti Blvd.Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Sadoghi University of Medical Sciences- Yazd
Full name of responsible person
Dr.Fateme Ezoddini Ardakani
Street address
Shahid Sadoghi University of Medical Sciences, Bahonar Sq., Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Sadoghi University of Medical Sciences- Yazd
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Oral Medicine Faculty of Dentistry Shahid Sadoghi University of Medical Sciences-Yazd
Full name of responsible person
Dr.Mahrooz Ershadi
Position
Resident(postgraduate student)
Other areas of specialty/work
Street address
Faculty of Dentistry , Dahe fajr Blvd., Yazd
City
Yazd
Postal code
Phone
+98 937 326 4731
Fax
Email
drershadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences-Yazd
Full name of responsible person
Dr.Hakimeh Ahadian
Position
Specialist
Other areas of specialty/work
Street address
Faculty of Dentistry, Dahe Fajr Blvd., Yazd
City
Yazd
Postal code
Phone
+98 35 1625 5881
Fax
Email
Drahadian@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoghi University of Medical Sciences- Yazd
Full name of responsible person
Dr.Mahrooz Ershadi
Position
Postgraduate student of oral medicine
Other areas of specialty/work
Street address
Faculty of Dentistry , Dahe Fajr Blvd. , Yazd
City
Yazd
Postal code
Phone
+98 937 326 4731
Fax
Email
drershadi@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)