The effect of zinc gluconate mouthwash in prevention of mucositis ,
Phase 3
- Conditions
- Acute Lymphoblastic Leukemia.Acute lymphoblastic leukemia [ALL]C91.0
- Registration Number
- IRCT20190202042583N3
- Lead Sponsor
- Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Age between 5 to 15 years old
Acute Lymphoblastic Leukemia under the treatment of Children's Oncology Group (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
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 Criteria 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 Criteria WHO.
- Secondary Outcome Measures
Name Time Method