Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan
Randomized, Double-Blind Study of FOND (Fosaprepitant, ONdansetron, Dexamethasone) Plus Either Olanzapine 2.5 mg Versus 5 mg for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients Receiving High-dose Melphalan Conditioning: The FONDO-LOW Study
Augusta University
172 participants
Sep 17, 2024
INTERVENTIONAL
Conditions
Summary
Patients who receive a chemotherapy called melphalan are at high risk of having nausea and vomiting. A medication called olanzapine has been shown to decrease nausea and vomiting after chemotherapy. A previous research study found the 10 mg dose of olanzapine (combined with 3 standard medications used routinely to prevent nausea/vomiting) to be effective for patients who received melphalan chemotherapy, but several other studies have shown many patients have a side effect of sleepiness (e.g., sedation) with that dose of the medication. Our study will compare two lower doses of olanzapine (5 mg and 2.5 mg) in combination with the 3 standard medications used to prevent nausea/vomiting in the patients who receive melphalan chemotherapy to determine which dose is effective in preventing nausea and vomiting with the lowest amount of sleepiness side effect.
Eligibility
Inclusion Criteria2
- Receipt of high-dose melphalan 140-200 mg/m2
- Autologous stem cell transplantation recipient
Exclusion Criteria6
- Allergy to olanzapine
- Documented nausea or vomiting within 24 hours prior to enrollment
- Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone within 30 days prior to enrollment or planned during protocol therapy
- Chronic alcoholism
- Pregnant
- Decline or unable to provide informed consent
Interventions
Subjects will be randomized to either olanzapine 2.5 mg or 5 mg
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06588413