Randomized, double-blind clinical trial of the use of mirtazapine versus megestrol for the control of anorexia-cachexia in cancer patients in palliative care

• Grant number: 18/04526-0
• Support type: Regular Research Grants
• Duration: September 01, 2018 - August 31, 2021
• Field of knowledge: Health Sciences - Medicine
• Principal researcher: Nereida Kilza da Costa Lima
• Grantee: Nereida Kilza da Costa Lima
• Home Institution: Faculdade de Medicina de Ribeirão Preto (FMRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil
• Assoc. researchers: Eduardo Ferriolli

Abstract

Cancer-associated anorexia cachexia is an insidious syndrome that has a major impact on the patient's quality of life, but is also associated with a significant reduction in survival. Despite its clinical importance, it remains a widely underestimated and untreated condition. Considering the scarcity of pharmacological measures, it is necessary to invest in studies that may contribute to the rational and effective treatment of this clinical condition. Mirtazapine has a special therapeutic potential because it is a well-tolerated drug with few adverse effects and with well-known orexigenic action in clinical practice. The objective of this study is to evaluate the effect of mirtazapine as a pharmacological measure in the management of cancer-related anorexia-cachexia in patients in palliative care. A randomized, double-blind clinical trial involving 52 cancer patients with anorexia-cachexia in palliative care will be conducted. Patients will be randomized to receive mirtazapine or megestrol and will be evaluated longitudinally for a period of 8 weeks. The primary endpoint will be to assess the effect of mirtazapine on anorexia and weight gain and secondary outcomes will be to assess the tolerability and safety of mirtazapine and the effect of mirtazapine on body composition, quality of life, and functional capacity of patients. (AU)