Comparison of the effect of chlorhexidine mouthwash and combined mouthwash (4 drugs) in the prevention and treatment of oral mucositis in neutropenic patients hospitalized in the pediatric oncology department of Shahid Sadoughi hospital, Yazd.
Comparison of the effect of chlorhexidine mouthwash and combined mouthwash (4 drugs) in the prevention and treatment of oral mucositis in neutropenic patients.
Design
A clinical trial with 2 intervention groups, with parallel groups, double-blind, randomized, phase 3 was conducted on 60 patients with acute lymphoid leukemia.
The randomization of the the two intervention groups is done based on quadruple blocks in Excel software.
Settings and conduct
The present study is conducted on children with acute lymphoid leukemia hospitalized in the oncology department of Shahid Sadoughi Hospital in Yazd. Patients who meet the inclusion criteria are randomly divided into two groups. Then the mouthwashes are given to the target patients in separate containers that have the same shape and each one is coded by a pediatric oncology nurse who does not know the type of mouthwash (she does not know the type of mouthwash). The code related to mouthwash containers is written separately in a specific place that only the researcher knows and will be evaluated later. Also, the liquids in the mouthwash containers are of the same color as agreed with the pharmacist consultant and are used by the patients.
Participants/Inclusion and exclusion criteria
Patients 2 to 18 years old, Patients with ALL have neutropenia
Patients undergoing chemotherapy with a single treatment protocol
Patients without oral mucositis
Intervention groups
Patients were randomly divided into two groups of 30 people, including one group intervention with the use of chlorhexidine mouthwash (0.2%) and an intervention group with the use of a combined mouthwash containing (diphenhydramine drugs in the amount of 25 cc, a full vial of nystatin 100,000 units per ml and 25 cc of aluminum-magnesium hydroxide and 4 drops of lidocaine 2%)
Main outcome variables
Severity of mucositis based on mucositis grading criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180209038673N8
Registration date:2024-07-19, 1403/04/29
Registration timing:prospective
Last update:2024-07-19, 1403/04/29
Update count:0
Registration date
2024-07-19, 1403/04/29
Registrant information
Name
Robab Sheikhpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3623 5958
Email address
r.sheikhpour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of chlorhexidine mouthwash and combined mouthwash (4 drugs) in the prevention and treatment of oral mucositis in neutropenic patients hospitalized in the pediatric oncology department of Shahid Sadoughi hospital, Yazd.
Public title
The effect of chlorhexidine mouthwash and combined mouthwash (4 drugs) in the prevention and treatment of oral mucositis in neutropenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ALL undergoing chemotherapy with the same treatment protocol
Patients with neutropenia without oral mucositis
Hospitalized patients in Shahid Sadoughi hospital
Exclusion criteria:
Lack of consent of the patient's parents
Age
From 2 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of the the two intervention groups is done based on quadruple blocks in Excel software. In this software, the intervention groups (A, and B) are placed alternately. In the next column, there are quadruple blocks. At the end, the random digits created by the software RND0 function are placed. We then arrange the numbers based on block columns and random values.
Blinding (investigator's opinion)
Double blinded
Blinding description
The mouthwashes are given to the patient (who does not know the type of mouthwash) in separate containers that have the same shape and the coding done by the nurse (clinical supervisor) of the pediatric oncology department (who does not know the type of mouthwash). The code for the container
Mouthwashes are written separately in a specific place that only the researcher knows and will be evaluated later. Also, the liquids in the mouthwash containers are of the same color as agreed with the pharmacist consultant and are used by the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Patients were randomly divided into two groups of 30 people, including an intervention group using chlorhexidine mouthwash (0.2%) and an intervention group using a combined mouthwash (containing 25 cc of diphenhydramine, a complete vial of 100,000 units/ml of nystatin). and 25 cc of aluminum-magnesium hydroxide and 4 drops of 2% lidocaine are placed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Alem Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2024-05-07, 1403/02/18
Ethics committee reference number
IR.SSU.MEDICINE.REC.1403. 036
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.02
ICD-10 code description
Acute lymphoblastic leukemia, in relapse
Primary outcomes
1
Description
Severity of mucositis
Timepoint
Oral intervention will be carried out for at least 1 month and twice a day, and patients will be clinically examined by a pediatric oncology specialist every week.
Method of measurement
Mucositis grading criteria (grade 0 to 4) according to WHO
Secondary outcomes
1
Description
Pain severity
Timepoint
Oral intervention will be carried out for at least 1 month and twice a day, and patients will be clinically examined by a pediatric oncology specialist every week.
Method of measurement
Using VAS score
Intervention groups
1
Description
Intervention group: Group 1 patients receive 0.2% chlorhexidine mouthwash twice a day for 1 month.
Category
Treatment - Drugs
2
Description
Intervention group: group 2 patients receive a combined mouthwash (containing 25 cc of diphenhydramine, a complete vial of nystatin 100,000 units per ml and 25 cc of aluminum-magnesium hydroxide and 4 drops of 2% lidocaine) twice a day for 1 month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Blood and Oncology, Shahid Sadoughi hospital
Full name of responsible person
Motahare Taghvaei
Street address
Department of Blood and Oncology, Shahid Sadoughi hospital, Riazi Square
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
motahare.taghvaei73@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi
Street address
Research and Technology Deputyو Imam Hossein Square
City
Yazd
Province
Yazd
Postal code
۷۴۶۱۶-۸۶۶۸۸.
Phone
+98 35 3628 7900
Email
motahare.taghvaei73@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Motahare Taghvaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Shahid Sadoughi Hospital, Riazi Square
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 8000
Email
motahare.taghvaei73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Motahare Taghvaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Shahid Sadoughi Hospital, Riazi Suare
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 8000
Email
motahare.taghvaei73@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Motahare Taghvaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Department of pediatrics, Shahid Sadoughi hospital, Riazi Square
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
motahare.taghvaei73@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available