Low Dose Olanzapine to the Prophylaxis of Nausea and Vomiting Induced by Chemotherapy in Children and Adolescents (OZONE-V)
Chemotherapy-induced Nausea and Vomiting
About this trial
This is an interventional treatment trial for Chemotherapy-induced Nausea and Vomiting
Eligibility Criteria
Inclusion Criteria:
- Age from 5 to 18 years.
- Body weight ≥ 30 kg.
- Confirmed diagnosis of malignancy.
- Planned at least 2 cycles of highly emetogenic chemotherapy according to the Pediatric Ontario Cancer Group (POGO) emetogenicity classification.
- ECOG status < 3.
- Adequate function of internal organs (bilirubin < 1.5 upper limit of normal (ULN), ALT and AST <2.5 ULN, creatinine < 1.5 ULN).
- Ability to swallow study drug.
- The presence of a written voluntary informed consent of the patient and / or his legal representative.
Exclusion Criteria:
- Treatment with olanzapine or another antipsychotic drug within the last 30 days.
- Planned use of antibiotics from the group of fluoroquinolones or other drugs that have drug interactions with olanzapine and other drugs used in the study (amifostin, citalopram, CYP1A2 inducers or inhibitors).
- The presence of intensive CINV against the background of a previous similar cycle of chemotherapy, which does not allow prescribing standard antiemetic prophylaxis upon inclusion in the study.
- The presence of a convulsive syndrome.
- Hypersensitivity to olanzapine or other drugs used in the study.
- Uncontrolled arterial hypertension or cardiovascular disorders, uncontrolled diabetes mellitus, or other diseases and conditions that, in the opinion of the physician, preclude study therapy.
- The presence of other factors (other than ongoing highly emetogenic therapy) that can cause the development of CINV (radiotherapy to the abdominal cavity or pelvis 1 week or less before inclusion in the study, obstruction of the gastrointestinal tract, uncontrolled intracranial hypertension, etc.).
- Severe CINV of any intensity 24 hours or less before the first dose of chemotherapy.
- Pregnancy or breastfeeding.
- Planned use of systemic glucocorticosteroids at the time of inclusion in the study.
Sites / Locations
- Zhukov NikolayRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control group
Olanzapine
Weight category 30-40 kg will receive: dexamethasone (5 mg/m2), ondansetron (0.15 mg/kg), aprepitant (80 mg) Weight category > 40 kg will receive: dexamethasone (5 mg/m2), ondansetron (0.15 mg/kg), aprepitant (125 mg) Note: aprepitant at a dose of 80 mg/day. applied for another 2 days, regardless of the number of days of chemotherapy.
Weight category 30-40 kg will receive: dexamethasone (5 mg/m2), ondansetron (0.15 mg/kg), aprepitant (80 mg), olanzapine (2.5 mg) Weight category > 40 kg will receive: dexamethasone (5 mg/m2), ondansetron (0.15 mg/kg), aprepitant (125 mg), olanzapine (2.5 mg for <55 kg, 5 mg for >55 kg) Note: aprepitant at a dose of 80 mg/day. applied for another 2 days, regardless of the number of days of chemotherapy.