Protocol summary

Study aim
The study of the effect of oral glucose in prevention of mucositis, following a high dose of methotrexate in children with acute lymphoblastic leukemia
Design
Based on the statistics advice and based on previous studies, 100 patient-episodes are studied. They are divided into two groups of 50 cases or control according to the random numbers table.
Settings and conduct
For the patient, starting with the 24-hour infusion, methotrexate is given every 8 hours for mouthwash and at least 30 seconds for oral mouthwash. In the control group, the patient receives a standardized oral mucosa (containing 100,000 units nystatin per cc + diphenhydramine 2.5 mg per cc + 260 cc MG aluminum syrup). The case group in each patient-the mouthpiece episode in the same container containing the above plus 16 grams in 260 cc of glutamine is used similarly. Patients are not aware of the type of mouthwash in each patient-episode. .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 5 to 10 years, ALL,treated by high dose of methotrexate, no mucositis before receiving methotrexate, no nausea and vomiting before starting methotrexate exclusion criteria:presence of fever, use of systemic or topical antibiotics
Intervention groups
Patients from 5 to 10 years old children with ALL who are admitted and treated in the blood and cancer boolea group are treated with a high dose of intravenous methotrexate (5 g / 24 hours infusion) in the Interim maintenance 1 protocol. Placed.
Main outcome variables
Sex، Age، The presence of mucositis، Mucositis intensity، Mucositis period، Number of nausea، The number of vomiting times، Number of feeds of fluids، The frequency of feeding solids

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190202042583N2
Registration date: 2020-09-05, 1399/06/15
Registration timing: retrospective

Last update: 2020-09-05, 1399/06/15
Update count: 0
Registration date
2020-09-05, 1399/06/15
Registrant information
Name
Mohammad Naderisorki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 7837
Email address
dr.naderisorki@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of glutamine mouthwash in prevention of mucositis following the administration of high doses of methotrexate in children with acute lymphoblastic leukemia
Public title
The effect of glutamine mouthwash in prevention of mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 5 to 10 years ALL under the treatment of COG chemotherapy protocol high dose of methotrexate no mucositis before receiving methotrexate no nausea and vomiting before starting methotrexate platelet count above 100,000 per μl before From the onset of methotrexate the absolute neutrophil count exceeds 1500 ml / μl before starting methotrexate hemoglobin above 8 g / l before starting methotrexate, the ability to use mouthwash for 30 seconds every 8 hours Absence of mucositis at the initial visit
Exclusion criteria:
presence of fever use of systemic or topical antibiotics
Age
From 5 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
After observing the inclusion criteria, a number is assigned to each patient at each time of drug administration. Then, based on the table of random numbers, the individual numbers in the control group and even numbers are placed in the case group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each patient will be informed by the dentist prior to receiving the drug in terms of the severity and severity of the mucositis. The dentist will not be aware of the patient who is rejected (case or control). For the patient, starting with the 24-hour infusion, methotrexate is given every 8 hours for mouthwash and at least 30 seconds for oral mouthwash.In the control group, the patient receives a standard oral mucosa (containing 100,000 units of nystatin in a cc + diphenhydramine 2.5 mg per cc + 260 cc of MG aluminum syringe). The case group in each patient uses the same oral mucosal epizood in the same container containing the above plus 16 grams in 260 cc of glutamine, The above mouthwash is prepared in coordination with the pharmacy department of the pharmacy of Bu Ali Hospital in Sari and under the supervision of the pharmacist's colleague, Dr. Sahraei. Patients are not aware of the type of mouthwash in each patient-episode The nurse in the oncology department monitors the proper use of mouthwash and, if not properly used, to be excluded from the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of mazandaran university of medical sciences
Street address
Central Headquarters of Mazandaran University of Medical Sciences,at the beginning of Valiasr Highway,Joibar Three Ways,Imam Square, Sari
City
Sari
Province
Mazandaran
Postal code
3397148157
Approval date
2019-12-18, 1398/09/27
Ethics committee reference number
IR.MAZUMS.REC.1398.1183

Health conditions studied

1

Description of health condition studied
acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]

Primary outcomes

1

Description
Severity of Mucositis
Timepoint
Before receiving the drug and re-day four after the onset of methotrexate
Method of measurement
By the dentist and according to the cafeteria WHO

2

Description
Existence of Mucositis
Timepoint
Before receiving the drug and re-day four after the onset of methotrexate
Method of measurement
By the dentist and according to the cafeteria WHO

3

Description
Periods of Mucositis
Timepoint
Before receiving the drug and re-day four after the onset of methotrexate
Method of measurement
By the dentist and according to the cafeteria WHO

4

Description
Frequency of nausea
Timepoint
Daily measurement
Method of measurement
Observation and clinical examination

5

Description
frequency of vomiting
Timepoint
Daily measurement
Method of measurement
Observation and clinical examination

6

Description
frequency of liquid nutrition
Timepoint
Daily measurement
Method of measurement
Observation and clinical examination

7

Description
Frequency of solids Nutrition
Timepoint
Daily measurement
Method of measurement
Observation and clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Each patient with ALL at the interim maintenance stage 1 needs to receive 5 episodes of high dose methotrexate. Each patient will be co-supervised by the dentist prior to receiving the drug in terms of the existence and severity of mucositis. The dentist from the group The patient will not be aware of it (case or control). The patient is given a mouthwash at least 30 seconds after starting the 24-hour infusion of methotrexate every 8 hours for mouthwash.The mouthwash is provided by the consultant pharmacist at the Faculty of Pharmacy.The studied mothers are not aware of the type of mouthwash in each patient-episode. The oncology nurse monitors the proper use of mouthwash and, if not used correctly, is excluded from the study. In both groups, the frequency of nausea and vomiting and Food intakes are recorded daily. People again on day 4 after starting methotrexate are checked out by a dentist who is a collaborator and mocositis is recorded according to the WHO criteria. If mucositis is present, again, on the 7th day, a dentist will examine the presence and severity of mucositis.
Category
Placebo

2

Description
Intervention group: Each patient with ALL at the interim maintenance stage 1 needs to receive 5 episodes of high dose methotrexate. Each patient will be co-supervised by the dentist prior to receiving the drug in terms of the existence and severity of mucositis. The dentist from the group The patient will not be aware of it (case or control). The patient is given a mouthwash at least 30 seconds after starting the 24-hour infusion of methotrexate every 8 hours for mouthwash. The case group in each patient uses the same oral mucosal episode in the same container containing the above plus 16 grams in 260 cc of glutamine, which is provided by the consultant pharmacist at the Faculty of Pharmacy.The studied mothers are not aware of the type of mouthwash in each patient-episode. The oncology nurse monitors the proper use of mouthwash and, if not used correctly, is excluded from the study. In both groups, the frequency of nausea and vomiting and Food intakes are recorded daily. People again on day 4 after starting methotrexate are checked out by a dentist who is a collaborator and mocositis is recorded according to the WHO criteria. If mucositis is present, again, on the 7th day, a dentist will examine the presence and severity of mucositis
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bu Ali Sina hospital
Full name of responsible person
Mohammad Naderisorki
Street address
Bu Ali Sina Hospital,Pasdarsn Boulevard,sari
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3334 3015
Email
dr.naderisorki@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
City
Sari
Province
Mazandaran
Postal code
3397148157
Phone
+98 11 3334 4506
Email
dr.naderisorki@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Naderisorki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
oncology
Street address
Bou Ali Sina Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 902 604 2132
Email
dr.naderisorki@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Naderisorki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Bou Ali Sina Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
009890266042132
Email
dr.naderisorki@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Naderisorki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Bou Ali Sina Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 902 604 2132
Email
dr.naderisorki@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
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
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