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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190202042583N2

Enrollment

100

Registered

2020-09-05

Start date

2019-06-22

Completion date

Unknown

Last updated

2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute lymphoblastic leukemia. Acute lymphoblastic leukemia [ALL]

Interventions

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 t

Eligibility

Sex/Gender

All

Age

5 Years to 10 Years

Inclusion 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

Exclusion criteria: presence of fever use of systemic or topical antibiotics

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Naderisorki

Mazandaran University of Medical Sciences

dr.naderisorki@gmail.com+98 902 604 2132

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026