Role of megestrol acetate versus dexamethasone for improvement in appetite in patients with cancer associated anorexia cachexia: A randomized controlled pilot trial

Abstract

Background: Loss of appetite, also known as anorexia, is a frequent and distressing symptom in patients with advanced cancer and other life-limiting illnesses. Prolonged periods of anorexia, can lead to both serious physical and psychological distress to patients and their families, which ultimately can contribute to a poorer quality of life. This study compare the clinical benefits between Dexamethasone and Megestrol acetate in an Indian setting, its positive impact on appetite, QOL, and lean body mass. Methods: A prospective, randomized controlled pilot study conducted in outpatient clinic of Palliative Medicine from September to December 2015. Registered adult advanced cancer patients meeting the inclusion criteria and exclusion criteria were assessed for anorexia, measured by ESAS scale, lean body weight (by Hume's Formula) and QOL (EORTC-QOL PAL15). Patients received either Dexamethasone (4mg) or MA (160mg in divided doses) for 21 days. No associated appetite stimulants or multivitamins were prescribed to study patients. All patients were encouraged to eat normal diet and provided standard medical care. Follow up done at days 7, 21 and 35. Results: Total 40 patients were enrolled in the study. Patients in both groups showed statistically significant improvement in appetite, lean body weight and quality of life at weeks 3 and 5, compared to baseline. However, study failed to show any significant difference for primary (appetite improvement) and secondary (lean body weight and quality of life) objectives between two groups, at weeks 3 and 5. Dexamethasone was found to be associated with more side effects. Conclusions: Comparison between Megestrol acetate and dexamethasone failed to show any statistical significant difference in improvement of anorexia, lean body weight and quality of life. Both drugs individually improved the same, as compared to baseline. Improvement in fatigue and other symptom scores were seen to be statistically significant in megestrol acetate arm. There is no significant difference in side effect profiles of both dexamethasone and megestrol acetate arms except for difficulty in standing from sitting position and nausea and vomiting.