Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 42
Summary
- Conditions
- Malignant Neoplasm
- Nausea
- Vomiting
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 outc...
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.
Tracking Information
- NCT #
- NCT03040726
- Collaborators
- National Cancer Institute (NCI)
- Helsinn Healthcare SA
- Investigators
- Principal Investigator: David Hui M.D. Anderson Cancer Center
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