An open-label phase III randomized controlled trial comparing metoclopramide, thalidomide, prochlorperazine, and lorazepam for treating breakthrough chemotherapy-induced nausea and vomiting in patients receiving olanzapine as part of antiemetic prophylaxis for highly emetogenic chemotherapy. - Nil

Cancer Institute WIA0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1.Age between 18 to 80 years and diagnosed with cancer.
•2.Patients with solid malignancies receiving single-day HEC with 4 drug (OPDF) antiemetic prophylaxis.
•3.Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
•4.Women enrolled in the trial need to have a negative pregnancy test within seven days of enrollment and continue to practice contraception during the study period.
•5.Patients with breakthrough vomiting and/or ESAS nausea score more than 3 which occur within 5 days of chemotherapy administration.
•6.Written informed consent before enrollment.

•1.Pediatric patients (age less than 18 years).
•2.Patients receiving lorazepam, thalidomide, prochlorperazine, or metoclopramide for other conditions.
•3.Patients receiving multi-day chemotherapy in a chemotherapy block.
•4.Patients with brain metastasis.
•5.Patients receiving abdominal radiotherapy.
•6.Patients in whom there are contraindications for the use of thalidomide, metoclopramide, prochlorperazine, or lorazepam like acute narrow-angle glaucoma, respiratory depression, sleep apnea, gastrointestinal hemorrhage, mechanical obstruction, or perforation.
•7.History of allergy to any of the drugs used for anti-emetic prophylaxis.
•8.Concomitant use of another benzodiazepine, opioids, or antipsychotics other than olanzapine during the protocol therapy.
•9.Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous six months.
•10.History of neurological disorders including seizures and stroke within the last 6 months.
•11.History of gastric outlet or intestinal obstruction; severe electrolyte disorder; history of symptomatic thrombosis; history or suspected likelihood of using narcotic analgesics; inability to take or absorb oral medicine.

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