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Does cryotherapy(using ice) decrease oral mucositis/ulcers in cancer patients

Efficacy of oral cryotherapy in the prevention of oral mucositis in children with hematolymphoid malignancies receiving IV Methotrexate-based chemotherapy: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040293
Enrollment
330
Registered
2022-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue

Interventions

Intervention1: Oral Cryotherapy: Flavored ice cubes Every 6 hours for 1 day Control Intervention1: Oral Hygiene: Daily Brushing and betadine gargles - twice daily

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Paediatric oncology patients aged 5-18 years receiving IV Methotrexate

Exclusion criteria

Exclusion criteria: 1. Consent not given 2. Patients having received prior radiotherapy to head/neck region 3. Patients having Diabetes Mellitus. 4. Patients receiving Methotrexate as a part of GVHD prophylaxis for HSCT. 5. Patients with a prior immunosuppressive disorder such as HIV.

Design outcomes

Primary

MeasureTime frame
To determine and compare the incidence of oral mucositis following IV methotrexate in paediatric oncology patients receiving oral cryotherapy versus standard of care.Timepoint: DAY 5, DAY 14 after recieving IV methotrexate—

Secondary

MeasureTime frame
To determine and compare the incidence of febrile neutropenia/infectious complications following IV methotrexate in paediatric oncology patients receiving oral cryotherapy versus standard of care.Timepoint: Day 5, day 14 after recieving IV methotrexate—

Countries

India

Contacts

Public ContactAditya Gupta

AIIMS, New Delhi

aditya5feb1995@gmail.com09990350017

Outcome results

None listed

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