Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induce… (NCT03478605) | Clinical Trial Compass
UnknownPhase 2
Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis
Russia130 participantsStarted 2018-05-25
Plain-language summary
Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. High-emetogenic chemotherapy (HEC) regimen (e.g., cisplatin ≥70 mg/m2 or doxorubicin ≥60 mg/m2 or carboplatin AUC≥4). Patients that are prescribed less doses of mentioned agents are still allowed if another high-emetogenic drug will be administered (eg, doxorubicin plus cisplatin);
✓. Administration of HEC component only in first day of the cycle;
✓. No previous chemotherapy or radiotherapy;
✓. No concomitant quinolone antibiotics administration;
✓. ECOG PS ≤2;
✓. No nausea and vomiting 24 hours before enrollment;
✓. Adequate hepatic and renal function (eg, ALaT, ASaT ≤3 ULN, creatinine clearance ≥50 ml/minute).
✓. No brain metastases, leptomeningeal carcinomatosis, and chronic diseases such as uncontrolled diabetes mellitus and chronic alcohol consumption.
Exclusion criteria
✕. Previous chemotherapy or radiotherapy;
✕. Moderate- or low- emetogenic chemotherapy;
✕. Multiday administration of HEC agents;
✕. ECOG PS \>2;
✕. History of brain metastases, signs of symptoms of bowel obstruction;