The effect of zinc gluconate mouthwash in prevention of mucositis ,

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2021
INTERVENTION: Intervention 1: Intervention group: Each patient is evaluated for the presence and severity of mucositis before receiving the drug by the dentist. For the patient, mouthwashWhich is performed every 8 hours from the start of the 24‐hour infusion of methotrexate which prepared in Mazandaran School of Pharmacy and keeping the mouthwash in the mouth for at least 30 seconds.In the intervention group, each patient uses mouthwash in the same container containing the above plus 1 mg / cc zinc gluconate Which has been prepared by the design consultant pharmacistin the same way. The patients studied are not aware of the type of mouthwash used in each patient‐episode. In both groups, the number of nausea and vomiting and daily food intake are recorded.Patients are re‐examined on the 4th day after the start of methotrexate by a partner dentist and the mucositis is registered according to the criteria of the World Health Organization. Intervention 2: Control group: Each patient will be co‐supervised by the dentist prior to receiving the drug in terms of the existence and severity of mucositis. The patient is given a mouthwash at least 30 seconds after starting the 24‐hour infusion of methotrexate Which was prepared in Mazandaran School of Pharmacy every 8 hours for mouthwash 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 mucositi. CONDITION: Acute Lymphoblastic Leukemia. ; Acute lymphoblastic leukemia [ALL] C91.0 PRIMARY OUTCOME: 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. 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. 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
Epistemonikos ID: 7487a6a58cb596747c2920be1f92b9c2c8b23b5b
First added on: Sep 02, 2021