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 Opportunities: Regular Research Grants
• Start date: September 01, 2018
• End date: August 31, 2021
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Nereida Kilza da Costa Lima
• Grantee: Nereida Kilza da Costa Lima
• Host Institution: Faculdade de Medicina de Ribeirão Preto (FMRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil
• Associated 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)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

ALMEIDA, OLGA LAURA SENA; FERRIOLLI, EDUARDO; TAVEIRA, ROBERTA CRISTINA CINTRA; ROSENBURG, MEIRE GALLO; CAMPANARI, DANIELA DALPUBEL; ALVES, NATALIA MAIRA DA CRUZ; PFRIMER, KARINA; RAPATONI, LIANE; PERIA, FERNANDA MARIS; LIMA, NEREIDA K. C.. Mirtazapine versus Megestrol in the Treatment of Anorexia-Cachexia Syndrome in Patients with Advanced Cancer: A Randomized, Double-Blind, Controlled Phase II Clinical Trial. CANCERS, v. 15, n. 14, p. 14-pg., 2023-07-01. (18/04526-0)