Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
Intervention1: 1. Fosaprepitant: • 12-18 years: 150 mg IV over 30 minutes.
• 4 years-less than 12 years: 4 mg/kg (maximum dose 150 mg) intravenously over 60 minutes.
Intervention2: 2. Palonosetron.:
Sponsors
Cancer Institute (WIA)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 4 to 18 years and diagnosed with cancer. Patients under four years have not been included as nausea assessment cannot be performed. 2. Receiving single-day regimen of moderately emetogenic chemotherapy (MEC). 3. Patients could have received prior chemotherapy. They need not be chemotherapy naïve. 4. Lansky play performance score of 60 or more for less than 16 years. Eastern Cooperative Oncology Group performance status of 0, 1, or 2 for 16-18 years. 5. Adequate organ function as confirmed by laboratory investigations within two weeks [Aspartate transaminase (AST) and Alanine transaminase (ALT) within four times upper limit of normal (ULN), serum bilirubin less than 2 mg/dL, serum creatinine within ULN]. 6. Written informed consent from parents before enrollment. Children above 7-12 years of age will need to provide verbal assent. Children between 13 and 18 years of age must provide written assent.
Exclusion criteria
Exclusion criteria: 1. Benzodiazepines or opioids are initiated 48 hours before treatment, except for single doses of triazolam, temazepam, or midazolam. 2. History of vomiting 24 hours before enrollment. 3. Use of antiemetics within 48 hours before treatment. 4. Patients receiving corticosteroids as a part of their chemotherapy protocol. 5. Patients with a primary brain tumor or brain metastasis. 6. Patients receiving concurrent radiotherapy with chemotherapy. 7. Patients in whom there are contraindications for corticosteroid use like uncontrolled diabetes mellitus, uncontrolled hypertension, active peptic ulcer disease and gastrointestinal bleeding. 8. History of allergy to any of the drugs used for anti-emetic prophylaxis. 9. Pregnant or breastfeeding patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To estimate and compare the proportion of patients with complete response (CR) for vomiting during the overall period between triple drug regimen (DPF) and two drug regimen for CINV prophylaxis (DP).Timepoint: 0-120 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the proportion of patients with complete response (CR) rates for vomiting during the acute period between triple drug regimen (DPF) and two drug regimen (DP) for CINV prophylaxis.Timepoint: 0-24 hrs;2. To compare the proportion of patients with complete response (CR) rates for vomiting during the delayed period between triple drug regimen (DPF) and two drug regimen (DP) for CINV prophylaxisTimepoint: 24-120 hrs;3. To compare the proportion of patients with CR to nausea for the overall, acute and delayed period period between triple drug regimen (DPF) and two drug regimen (DP) for CINV prophylaxis.Timepoint: 0-120 hrs;4. To compare the grade 3 and grade 4 toxicities between the two regimensTimepoint: 0-120 hrs | — |
Countries
India
Contacts
Public ContactPrasanth Srinivasan
Department of Medical Oncology, Division of Pediatric Oncology, Cancer Institute (WIA)
Outcome results
None listed