Ice popsicles for prevention of oral ulcer following anti-cancer therapy in children suffering from blood cancer.

Oral Cryotherapy for prevention of Oral mucositis following high dose methotrexate in children with Acute Lymphoblastic Leukemia: A Randomised controlled study. - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066130

Enrollment

Registered

2024-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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: Oral Cryotherapy: The children in the cryotherapy group will be instructed to cool their mouths by keeping ice popsicles for as long as possible but for minimum of 30 mins every 6 hours

Eligibility

Inclusion criteria

Inclusion criteria: Children (aged 2 to 18 years) suffering from acute lymphoblastic leukemia, who are due for high-dose methotrexate therapy.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Percentage of children with ALL who developed oral mucositis in oral cryotherapy group v/s no oral cryotherapy group. 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	—

Measure

Time frame

Percentage of children with ALL who developed oral mucositis in oral cryotherapy group v/s no oral cryotherapy group. 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

Measure	Time frame
The severity of oral mucositis with and without Oral cryotherapy in terms of (a) WHO grading of Oral mucositis And CHIMES Scale, (b) Onset and duration of mucositis (in days). (c) use of analgesics (whether used or not) (d) need for hospitalization • Feasibility (no. of minutes for which child is able to suck on Ice popsicles in each session of 24hr chemotherapy duration will be added.)Timepoint: The severity of oral mucositis with and without Oral cryotherapy in terms of (a) WHO grading of Oral mucositis And CHIMES Scale, (b) Onset and duration of mucositis (in days). (c) use of analgesics (whether used or not) (d) need for hospitalization • Feasibility (no. of minutes for which child is able to suck on Ice popsicles in each session of 24hr chemotherapy duration will be added.)	—

Measure

Time frame

The severity of oral mucositis with and without Oral cryotherapy in terms of (a) WHO grading of Oral mucositis And CHIMES Scale, (b) Onset and duration of mucositis (in days). (c) use of analgesics (whether used or not) (d) need for hospitalization • Feasibility (no. of minutes for which child is able to suck on Ice popsicles in each session of 24hr chemotherapy duration will be added.)Timepoint: The severity of oral mucositis with and without Oral cryotherapy in terms of (a) WHO grading of Oral mucositis And CHIMES Scale, (b) Onset and duration of mucositis (in days). (c) use of analgesics (whether used or not) (d) need for hospitalization • Feasibility (no. of minutes for which child is able to suck on Ice popsicles in each session of 24hr chemotherapy duration will be added.)

—

Countries

India

Contacts

Public ContactDr Sampada Anil Kumar kaul

ABVIMS and Dr RML HOSPITAL NEW DELHI

drshilpakhanna@yahoo.co.in9310112085

Outcome results

None listed

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