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pomegranate popsicles for prevention of oral mucositis in children with ALL receiving High dose methotrexate.

" A pilot study to assess the feasibility of pomegranate popsicles for prevention of oral mucositis during administration of high dose methotrexate in children with ALL at TMH"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033650
Enrollment
50
Registered
2021-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Intervention1: Pomegranate Popsicles (oral cryotherapy ): The care giver is taught about the preparation of pomegranate popsicles and explained to prepare the popsicles 6 hour before the starting the

Sponsors

DrMrs Manisha Pawar
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. To find the incidence of oral mucositis among children receiving High dose methotrexate after administration of oral cryotherapy . 2. To evaluate the effectiveness of oral cryotherapy on oral mucositis (the intensity ,duration of mucositis, use of pain medication ,pain scores). Timepoint: Incidence of oral mucositis will be assessed at the end of week1,week2,week3and week 4 of the treatment protocol. Effectiveness of oral cryotherapy will be assessed at the end of weel1,week2,week3 and week4 of the treatment protocol.

Countries

India

Contacts

Public ContactGiby Justin perumattil

Tata Memorial Hospital

manisha19pawar@gmail.com7738059723

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026