70 PART TWO | CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING DEX-sparing strategies consisting of single-dose DEX plus palonosetron, or a three-drug regimen with single-dose DEX plus the 5-HT3 RA ondansetron and metoclopramide on days 2-3, both compared with standard 3-day DEX plus ondansetron. The objective was to demonstrate noninferiority of both DEX-sparing regimens to standard treatment in terms of control of delayed CINV with a focus on delayed nausea. Patients and methods Study design This multicenter, open-label, randomized, phase III, noninferiority trial included patients at 6 enrolling sites in the Netherlands between June 2014 and June 2018. The institutional review board or ethics committee of each study site reviewed and approved the study protocol. All patients provided written informed consent according to international guidelines before treatment entry. The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization guideline for Good Clinical Practice. This study was registered in ClinicalTrials.gov (number NCT02135510). Patients Eligible patients were ≥18 years, naïve to chemotherapy, able to speak and read the Dutch language fluently, and scheduled to receive the first course of MEC for treatment of a histologically or cytologically confirmed solid tumor malignancy. MEC agents could be administered intravenously (IV) as single agents or in combination with chemotherapy agents with low or minimal emetogenic potential. Patients were required to have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1, and acceptable hematologic, hepatic, and renal functions. Patients were not eligible if theywere scheduled to receive radiotherapy within 2weeks before initiation of chemotherapy or between days 1 and 8 after the administration of chemotherapy. Additional exclusion criteria were: receipt of medication with antiemetic effectup to 48 hr before chemotherapy; vomiting, retching or mild nauseaup to 48 hr before chemotherapy; serious comorbidity conditions such as intestinal obstruction, active peptic ulcer, hypercalcemia, uncontrolled diabetes mellitus, pheochromocytoma, brain – or leptomeningeal metastases, parkinsonism, epilepsy, or psychiatric disorders. Patients with a history of alcohol abuse or concurrent use of corticosteroids (similar to prednisone ≥10 mg), and pregnant or nursing women were also excluded. Procedures and outcomes Eligible patients were randomly assigned (1:1:1 ratio) to receive study treatment. The method for concealment of allocation was by enclosing assignments in sequentially numbered, opaque, sealed envelopes provided by an independent third party (university medical center pharmacist). The envelopes were opened sequentially, and only after the envelope had been irreversibly assigned to the participant. Investigators who evaluated treatment response were not masked to group assignment. The allocated treatment was not masked to the respective patients and treatment physicians. However, treatment assignments were concealed from the institutions and patients until registration. In
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