Health Condition 1: C910- Acute lymphoblastic leukemia [ALL] Health Condition 2: C859- Non-Hodgkin lymphoma, unspecified Health Condition 3: C858- Other specified types of non-Hodgkin lymphoma
Conditions
Interventions
Intervention1: Oral hydration: Hydration would be provided by oral fluids that are part of a routine diet including water, milk, coconut water, clear soups etc. Parents would be provided with calibrat
Sponsors
Dr Aditya Kumar Gupta
Eligibility
Inclusion criteria
Inclusion criteria: Established diagnosis of hematolymphoid malignancy (acute lymphoblastic leukemia, Non-Hodgkin lymphoma) - primary or relapsed disease On chemotherapy protocol requiring high dose methotrexate (HDMTX) (>=1g/m2/dose) Eligible for HDMTX administration as per unit protocol and chemotherapy protocol Atleast one previous course of HDMTX uneventfully administered with intravenous alkaline hydration.
Exclusion criteria
Exclusion criteria: Prior to start of HDMTX: MTX toxicity during previous courses of HDMTX. Requirement of intravenous hydration or intravenous alkalinization for any other reason (e.g. concurrent chemotherapy requiring intravenous hydration) After the MTXT1: Unsafe MTXT1 Clinical features of MTX toxicity Nausea - Grade 3 and above Vomiting - Grade 3 and above Oral mucositis - Any grade Fever - temperature > 100.4 F Contraindication to enteral feeds e.g. ileus Withdrawal criteria (after enrolment): Failure to place NG tube due to patient denial or uncooperative child when IARTa is Unsafe MTXT2 Nausea - Grade 3 and above Vomiting - Grade 3 and above Oral mucositis - Any grade Fever - temperature > 100.4 F Contraindication to enteral feeds e.g. ileus, neutropenic enterocolitis Requirement of more than 2 bolus doses of oral sodium bicarbonate to maintain target urine pH of 7.0 â?? 8.0 Urine output measured from time point p to time point c is Failed repeat oral dose of sodium bicarbonate or leucovorin 20 minutes after a vomited dose. More than 2 episodes of vomited oral sodium bicarbonate or leucovorin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion of course on oral hydration regimenTimepoint: 54 hours from start of high dose methotrexate infusion; at the end of oral hydration regimen, when oral LV rescue is complete. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative adherence rate (CAR): Proportion of required volume of fluid actually taken by the child, calculated for the total duration of oral hydration.Timepoint: Time point at the end of oral hydration regimen, when oral LV rescue is complete.;Median change in serum sodiumTimepoint: The time in hours from the start of intravenous methotrexate infusion at which the first serum methotrexate level is measured, given that the time point at the start of intravenous methotrexate infusion is 0 hours. Time point at the end of oral hydration regimen, when oral LV rescue is complete.;MTX T2 - Serum methotrexate level at timepoint T2Timepoint: Time point 2 (T2): The time in hours from the start of intravenous methotrexate infusion at which the second serum methotrexate level is measured, given that the time point at the start of intravenous methotrexate infusion is 0 hours.;Need for NG placementTimepoint: A time point 24 hours from the start of oral hydration regimen.;Occurrence of Febrile neutropenia, Anemia: Grade 3 or more, Thrombocytopenia: any grade, Nausea: Grade 2 or more, Vomiting: Grade 2 or more, Oral mucositis, Transaminasemia, Hyperbiliruinemia, Elevated creatinine, DermatitisTimepoint: Until the start of next course of HDMTX or 28 days from start of HDMTX, whichever is earlier. | — |
Countries
India
Contacts
Public ContactKarri Padma Sagarika
All India Institute of Medical Sciences New Delhi
Outcome results
None listed