Ice popsicles for prevention of oral ulcer following anti-cancer therapy in children suffering from blood cancer.
Phase 2
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2024/04/066130
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children (aged 2 to 18 years) suffering from acute lymphoblastic leukemia, who are
due for high-dose methotrexate therapy.
Exclusion Criteria
1.Children who are not co-operative
2.Children suffering from kidney disease or having deranged Kidney Function Test.
3.Children having pre-existing Oral mucositis or Oral Aphthous ulcer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of children with ALL who developed oral mucositis in oral <br/ ><br>cryotherapy group v/s no oral cryotherapy group. <br/ ><br>Timepoint: Investigator will check for signs of oral mucositis after 24 hr methotrexate infusion is over and when the patient comes for subsequent high dose methotrexate infusion after 2 weeks. Patient will also be asked to inform the investigator if any symptoms of oral mucositis occur during the 2 week interval between 2 subsequent doses
- Secondary Outcome Measures
Name Time Method The severity of oral mucositis with and without Oral cryotherapy in terms of <br/ ><br>(a) WHO grading of Oral mucositis And CHIMES Scale, <br/ ><br>(b) Onset and duration of mucositis (in days). <br/ ><br>(c) use of analgesics (whether used or not) <br/ ><br>(d) need for hospitalization <br/ ><br>• Feasibility <br/ ><br>(no. of minutes for which child is able to suck on Ice popsicles in each session <br/ ><br>of 24hr chemotherapy duration will be added.)Timepoint: The severity of oral mucositis with and without Oral cryotherapy in terms of <br/ ><br>(a) WHO grading of Oral mucositis And CHIMES Scale, <br/ ><br>(b) Onset and duration of mucositis (in days). <br/ ><br>(c) use of analgesics (whether used or not) <br/ ><br>(d) need for hospitalization <br/ ><br>• Feasibility <br/ ><br>(no. of minutes for which child is able to suck on Ice popsicles in each session <br/ ><br>of 24hr chemotherapy duration will be added.)