Riechelmann, R.P., Burman, D., Tannock, I.F., Rodin, G., & Zimmermann, C. (2010). Phase II trial of mirtazapine for cancer-related cachexia and anorexia. American Journal of Hospice and Palliative Care, 27, 106–110.doi: 10.1177/1049909109345685
To determine the proportion of patients who gained at least 1 kg at the end of week 4. Secondary endpoints were the proportion of patients whose appetite or health-related quality of life (HRQOL) improved at week 4.
Patients received the starting dose of 15 mg of mirtazapine orally at bedtime for three days. Thereafter they received 30 mg daily provided they tolerated the medication. Patients were weighed on a mechanical scale and were assessed for appetite change and side effects prior to starting the mirtazapine and at weeks 2, 4, and 8. HQOL was measured at baseline and at weeks 4 and 8. Demographics (age, gender, concurrent medications, disease site, and Eastern Cooperative Oncology Group performance status) were also assessed. Toxicity was assessed at every visit.
The study was an eight-week, open-label, noncomparative phase II trial.
At week 4, 4 of 17 patients (24%) had weight gain of 1 kg or more (range: 1–3.6 kg). One patient maintained weight, and two patients lost weight. Of the patients who gained weight, all improved by 2 or more points on the ESAS for appetite (range = 2–6 points). One of the responding patients demonstrated improved HQOL by 16 points, and three maintained HQOL. Mirtazapine was well tolerated, but two patients withdrew from the study due to side effects.
Nearly a quarter of patients in this study gained at least 1 kg after four weeks of therapy. Another quarter maintained their weight. While the results of the study indicate that mirtazapine appears to be a potentially useful agent in the management of cancer-related cachexia and anorexia, this study was small, with only four patients in each group.
The pathophysiology of cachexia is complex. There is currently no standard treatment for managing cancer-related cachexia. Mirtazapine may be a potential agent useful in the management of cachexia; however, additional research is necessary.