Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
Intervention1: oral glutamine mouth wash with oral standard hygiene protocol: Children in the intervention arm will receive oral glutamine mouth wash (5 g twice daily swish and swallow method)
Glutam
Sponsors
University College Of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 3-12 years diagnosed with ALL receiving HDMTX (2g/m2/dose) in the consolidation phase (BFM 2009 ALL Protocol)
Exclusion criteria
Exclusion criteria: Patients with oral mucositis prior to chemotherapy, severe systemic sepsis/ critically ill patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of events of severe mucositis (grade III or IV as per WHO grading) in both groupsTimepoint: Day 7 to day 56 of consolidation | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ No. of events of mucositis in both groups as assessed by WHO grading of mucositis â?¢ Duration of mucositis in children in both groups â?¢ No. of events of painful (VAS score â?¥ 8) mucositis in both groups â?¢ Proportion of events needing rescue therapy â?¢ No. of events of oral infections in both groups Timepoint: Day 7 to day 56 of consolidation | — |
Countries
India
Contacts
Public ContactSIVA SANKARAN S
UNIVERSITY COLLEGE OF MEDICAL SCIENCES, DELHI
Outcome results
None listed