pomegranate popsicles for prevention of oral mucositis in children with ALL receiving High dose methotrexate.
Not Applicable
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2021/05/033650
- Lead Sponsor
- DrMrs Manisha Pawar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Children age with Acute lymphoblastic leukemia(ALL) age group from 5years to 18yearsreceiving HDMTX interim Maintenance cycle.
2.Parents of children who gave consent and who can follow instructions.
Exclusion Criteria
1.Children who are developmentally or physically unable to perform the intervention .
2.Parents of children who are not willing to participate.
3. Children having neutropenia defined as absolute neutrophil count (ANC) <1500/mm3 had excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess ease and tolerability of oral cryotherapyTimepoint: For administration of high dose methotrexate ,ease and tolerability of oral cryotherapy will be assessed weakly once or 3 weekly once.
- Secondary Outcome Measures
Name Time Method 1. To find the incidence of oral mucositis among children receiving High dose methotrexate after administration of oral cryotherapy . <br/ ><br>2. To evaluate the effectiveness of oral cryotherapy on oral mucositis (the intensity ,duration of mucositis, use of pain medication ,pain scores). <br/ ><br>Timepoint: Incidence of oral mucositis will be assessed at the end of week1,week2,week3and week 4 of the treatment protocol. <br/ ><br> <br/ ><br>Effectiveness of oral cryotherapy will be assessed at the end of weel1,week2,week3 and week4 of the treatment protocol.