Nausea Clinical Trial
Official title:
Fixed-Dose Netupitant and Palonosetron for Chronic Nausea and Vomiting in Cancer Patients
This randomized phase II/III trial studies how well netupitant and palonosetron hydrochloride works in preventing chronic nausea and vomiting in patients with cancer. Netupitant and palonosetron hydrochloride may reduce nausea and vomiting.
PRIMARY OBJECTIVES: I. To estimate the efficacy (i.e. change in nausea numeric rating scale [NRS] from baseline between day 5-15) of fixed dose netupitant and palonosetron hydrochloride (palonosetron) (NEPA) for chronic nausea in cancer patients. SECONDARY OBJECTIVES: I. To assess the secondary outcomes (e.g. proportion of patients who achieved their personalized nausea goal, antiemetic use, nausea episodes duration/frequency) for NEPA versus (vs.) placebo. II. To assess the adverse effects associated with NEPA and placebo. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive netupitant orally (PO) and palonosetron hydrochloride PO on days 1, 6, and 11 in the absence of disease progression or unacceptable toxicity. GROUP II: Patients receive placebo PO on days 1, 6, and 11. ;
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