A Phase 3 interventional study of Ondansetron and Dexamethasone in Chemotherapy-induced Nausea and Vomiting, sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology. Status unknown at 1 site in Russian Federation. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-07-28.
Sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Phase 3, Interventional, and Treatment
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, achieves complete control in less than 50% of patients. Studies have shown that the addition of large doses of olanzapine improves control, including in children and adolescents. However, olanzapine has not yet been included in standard recommendations in the pediatric population. Studies in adults indicate that the dose of the drug can be halved without loss of effectiveness and with a decrease in toxicity. This open-label, randomized, phase III trial evaluates the efficacy and safety of adding low-dose olanzapine to standard prevention of nausea and vomiting induced by highly emetogenic chemotherapy in children and adolescents.
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 first cycle of highly emetogenic chemotherapy with standard prophylaxis (5-HT3 receptor antagonist, dexamethasone, aprepitant) with or without addition of 0.07 mg/kg olanzapine (rounded to multiples of 2.5 mg, maximum 5 mg). During chemotherapy and 120 hours after its completion, patients are assessed for the presence and absence, as well as the severity of CINV, the need for "rescue" therapy, and the development of adverse events. In the future, patients undergo a similar course of highly emetogenic chemotherapy with a change in the antiemetic prophylaxis option - crossover (patients who received an olanzapine regimen as antiemetic prophylaxis after the first cycle of chemotherapy receive treatment without it, patients who received prophylaxis without olanzapine receive a second cycle of therapy with olanzapine). After this cycle, the presence and absence, as well as the severity of CINV, the need for salvage therapy, the development of adverse events are assessed and, additionally, at the end of the cycle, patients are asked about the preferred option for further antiemetic prophylaxis (the regimen with olanzapine, no olanzapine, or no preferences).
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's planned enrollment of 210 is above the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →Federal Research Institute of Pediatric Hematology, Oncology and Immunology is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1. Weight category 30-40 kg will receive: dexamethasone (5 mg/m2), ondansetron (0.15 mg/kg), aprepitant (80 mg) 2. 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.
Drug: Ondansetron · Drug: Dexamethasone · Drug: Aprepitant
1. Weight category 30-40 kg will receive: dexamethasone (5 mg/m2), ondansetron (0.15 mg/kg), aprepitant (80 mg), olanzapine (2.5 mg) 2. 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.
Drug: Ondansetron · Drug: Dexamethasone · Drug: Aprepitant · Drug: Olanzapine
Ondnsetron will be administered at a dose of 0.15 mg/kg IV/PO every 8 hours on the day(s) of chemotherapy and 3 days after completion of chemotherapy
Dexamethasone will be administered at a dose of 5 mg/m2 intravenously/orally once on the day(s) of chemotherapy and 3 days after completion of chemotherapy;
Aprepitant will be administered based on body weight: body weight 30-40 kg: days 1-3 - 80 mg orally; body weight \> 40 kg: day 1 - 125 mg orally, days 2, 3 - 80 mg orally
Olanzapine will be administered at a dose of 0.07 mg/kg orally on the day(s) of chemotherapy and 3 days after completion of chemotherapy (rounded up to the maximum multiple of 2.5 mg, maximum daily dose of 5 mg).
Complete control of vomiting
proportion of patients who did not have episodes of vomiting and/or use of additional antiemetic drugs (rescue therapy) during the chemotherapy cycle and within 120 hours after its completion
Time frame: up to 21 days
Patient preference
Proportion of patients who, after crossover, chose to continue treatment with an experimental regimen including olanzapine
Time frame: up to 42 days
Adverce events
Percentage of patients with grade 3-4 adverse events according to CTCAE v. 5.0. \[Time frame: day(s) of chemotherapy administration and 120 hours after chemotherapy administration\]
Time frame: up to 42 days
Complete control of acute vomiting
Proportion of patients who did not have episodes of vomiting and/or use of additional antiemetic drugs (rescue therapy) during the chemotherapy cycle and within 24 hours after its completion
Time frame: up to 21 days
Complete control of chemotherapy-induced nausea and vomiting (CINV)
Proportion of patients who did not experience nausea (PeNAT score 1) and/or vomiting and/or use of additional antiemetics (rescue therapy) during the chemotherapy cycle and within 120 hours after its completion
Time frame: up to 21 days
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Federal Research Institute of Pediatric Hematology, Oncology and Immunology