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IRCT20190202042583N2 IRCT 2020-09-05 Mazandaran University of Medical Sciences The effect of glutamine mouthwash in prevention of mucositis The effect of glutamine mouthwash in prevention of mucositis following the administration of high doses of methotrexate in children with acute lymphoblastic leukemia 2019-06-22 anticipated 100 Complete https://irct.ir/trial/37313 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 acute lymphoblastic leukemia. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The results will be published later
public Mohammad Naderisorki
Bou Ali Sina Hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 902 604 2132 dr.naderisorki@gmail.com Mazandaran University of Medical Sciences scientific Mohammad Naderisorki
Bou Ali Sina Hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 009890266042132 dr.naderisorki@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 5 years 10 years Both presence of fever use of systemic or topical antibiotics C91.0 Acute lymphoblastic leukemia [ALL] Placebo Treatment - Drugs 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. 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 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. 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. 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. Frequency of nausea. Timepoint: Daily measurement. Method of measurement: Observation and clinical examination. Frequency of vomiting. Timepoint: Daily measurement. Method of measurement: Observation and clinical examination. Frequency of liquid nutrition. Timepoint: Daily measurement. Method of measurement: Observation and clinical examination. Frequency of solids Nutrition. Timepoint: Daily measurement. Method of measurement: Observation and clinical examination. Mazandaran University of Medical Sciences Approved 2019-12-18 Ethics committee of mazandaran university of medical sciences Central Headquarters of Mazandaran University of Medical Sciences,at the beginning of Valiasr Highway,Joibar Three Ways,Imam Square, Sari Sari Mazandaran Iran (Islamic Republic of)