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A study to compare efficacy of oral hydration versus intravenous hydration during high dose methotrexate chemotherapy in children with hematolymphoid malignancies

Efficacy of oral route supportive care regimen versus conventional intravenous hydration during high dose methotrexate chemotherapy in children with hematolymphoid malignancies: A randomized open label non-inferiority trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073505
Enrollment
100
Registered
2024-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Oral route supportive care regimen: Oral route supportive care regimen includes oral hydration, oral sodium bicarbonate, and oral leucovorin. Oral hydration will be provided with oral f

Sponsors

Dr Ruksana Sidhique PR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children fulfilling prerequisites of high dose methotrexate administration as per the existent unit protocol 2. Children who had safe drug level after 24 hours of infusion with methotrexate

Exclusion criteria

Exclusion criteria: 1. Children with features of methotrexate toxicity Vomiting (grade 2 or above) Oral mucositis (grade 2 or above) 2.Any contraindication to oral feeds if present like paralytic ileus/subacute intestinal obstruction 3.Requirement of intravenous hydration or intravenous alkalinization for any other reason (e.g.concurrent chemotherapy requiring intravenous hydration)

Design outcomes

Primary

MeasureTime frame
To identify the efficacy of an oral supportive care regimen versus conventional intravenous hydration during high-dose methotrexateTimepoint: Upto completion of leucovorin rescue as per protocol—

Secondary

MeasureTime frame
To compare proportion of children with adverse events in both armsTimepoint: Until start of next high dose methotrexate or 14 days from start of high dose methotrexate;To determine mean cumulative adherence in intervention armTimepoint: Up to completion of leucovorin rescue as per protocol;To identify proportion of courses requiring nasogastric tube placement for fluid administration in the intervention armTimepoint: Up to completion of leucovorin rescue as per protocol—

Countries

India

Contacts

Public ContactDr Jagdish Prasad Meena

AIIMS New Delhi

drjpmeena@gmail.com8890139358

Outcome results

None listed

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