Status:
UNKNOWN
Low Dose Olanzapine to the Prophylaxis of Nausea and Vomiting Induced by Chemotherapy in Children and Adolescents
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions:
Chemotherapy-induced Nausea and Vomiting
Eligibility:
All Genders
5-18 years
Phase:
PHASE3
Brief Summary
Chemotherapy-induced nausea and vomiting continues to be a significant problem in children and adolescents. Standard antiemetic therapy, including a 5-HT3 antagonist, aprepitant, and a corticosteroid,...
Detailed Description
After signing informed consent, eligible patients are randomized with stratification (previously received or not received high emetogenic therapy; regimens with and without cisplatin) to receive the f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT05346731
Start Date
April 1 2022
End Date
August 1 2024
Last Update
July 28 2022
Active Locations (1)
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1
Zhukov Nikolay
Moscow, Russia, 117997