Glutamine Mouthwash for Preventing Chemotherapy-induced Oral Mucositis in Children with Blood Cancer
Not Applicable
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2022/11/047563
- Lead Sponsor
- niversity College Of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Patients with oral mucositis prior to chemotherapy, severe systemic sepsis/ critically ill patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method â?¢No. of events of mucositis in both groups as assessed by WHO grading of mucositis <br/ ><br>â?¢Duration of mucositis in children in both groups <br/ ><br>â?¢No. of events of painful (VAS score â?¥ 8) mucositis in both groups <br/ ><br>â?¢Proportion of events needing rescue therapy <br/ ><br>â?¢No. of events of oral infections in both groups <br/ ><br>Timepoint: Day 7 to day 56 of consolidation