Anti-Emetic Prophylaxis for Chemotherapy-Induced Vomiting Without Dexamethasone for Children and Adolescents Receiving Highly Emetogenic Chemotherapy: Investigator-
Initiated, Open-Label, Multi-Center, Non-Inferiority, Phase III Randomized Controlled Trial.
● Principal Investigator: Dr. Venkatraman Radhakrishnan
To study the efficacy and safety of the dexamethasone free OPF regimen as prophylaxis for CINV in pediatric patients receiving highly emetogenic (HEC) in comparison to the dexamethasone containing DPF regimen.
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, dosing with olanzapine
is not possible with the currently available tablet formulations, and data on olanzapine safety is unavailable.
2. Weight above 10 kg.
3. Receiving single-day or multi-day highly emetogenic chemotherapy (HEC) in a block.
4. Patients could have received prior chemotherapy. They need not be chemotherapy naïve.
5. Absence of vomiting 24 hours before enrollment.
6. 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.
7. 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].
8. 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.
1. Patients receiving steroids as part of the chemotherapy regimen or steroids are
needed as pre-medication to prevent allergic reactions.
2. Initiation of systemic corticosteroids within 72 hours before study drug
administration.
3. Benzodiazepines or opioids are initiated 48 hours before treatment, except for
single doses of triazolam, temazepam, or midazolam.
4. Use of antiemetics within 48 hours of treatment.
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. Treatment with another antipsychotic agent such as risperidone, quetiapine,
clozapine, phenothiazine, or butyrophenone for 30 days before or during the
protocol therapy.
10. Receipt of mediation known to interact with olanzapine (e.g. fluoxetine, carbamazepine, omeprazole, rifampin).
11. A baseline ECG with clinically significant abnormalities, including QTc prolongation (≥450 milliseconds).
12. Receipt of medication that may increase the potential for olanzapine toxicity.
13. Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous six months.
14. History of a neurological disorder including seizures and stroke within last six months.
15. Pregnant or breastfeeding patients.
Missing