This phase II trial studies the effects of mirtazapine in treating patients with glioma who experience depression and temozolomide-induced nausea and vomiting. Patients undergoing temozolomide treatment may experience depression, severe nausea, vomiting episodes, and decreased appetite. Mirtazapine may help reduce nausea, sleep disturbance, pain, loss of appetite, and depression. The purpose of this research study is to find out whether mirtazapine will relieve depression, severe nausea, vomiting and decreased appetite in glioma patients who undergo temozolomide treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03935685.
PRIMARY OBJECTIVES:
I. To administer the Beck Depression Inventory to approximately 100 patients meeting the inclusion/exclusion criteria in order to identify at least 36 with clinical depression (defined as total score >= 21).
II. To put at least 36 clinically depressed patients identified in aim one on mirtazapine for eight weeks.
III. To administer the Beck Depression Inventory to patients from aim two at four weeks and at eight weeks of treatment with mirtazapine.
IV. To document weight and frequencies of nausea, vomiting, and insomnia among participants over the course of the study.
V. To document adverse events experienced by participants over the course of the study and determine, to the extent possible, if mirtazapine is the cause.
OUTLINE:
Patients receive mirtazapine orally (PO) once daily (QD) in the evening in the absence of disease progression or unacceptable toxicity.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUC Irvine Health/Chao Family Comprehensive Cancer Center
Principal InvestigatorDaniela A. Bota
