The effect of glutamine mouthwash in prevention of mucositis

Phase 3

• Conditions: acute lymphoblastic leukemia.; Acute lymphoblastic leukemia [ALL]; C91.0

• Registration Number: IRCT20190202042583N2
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.