Randomised, double blind control trial of megestrol acetate, dexamethasone and placebo in the management of anorexia in people with cancer

This study compared megestrol acetate 480 mg/day with dexamethasone 4 mg/day for the overall effects on appetite. Patients with advanced cancer and anorexia for 2 weeks with a score of 4 out of 10 (using a 0-10 numeric rating scale (NRS) where 0 = no appetite, and 10 = best possible appetite) were recruited. Participants received megestrol 480 mg or dexamethasone 4 mg or placebo daily for up to 4 weeks. The primary outcomes were measured on day 7. People who responded to the treatment were defined as having a 25% improvement in appetite score from the baseline score, where the score for appetite at baseline was expected to score higher. There were 190 people randomised (megestrol acetate n = 61; dexamethasone n = 67, placebo n = 62). At week 1 (primary endpoint), 79·3% in the megestrol group, 65·5% in the dexamethasone group and 58·5% in the placebo group (p = 0.067) had responded, that is these people had shown a 25% improvement in the score for appetite. No differences in performance status or quality of life were reported. Adverse events (side effects) that emerged while on one of the 3 treatments were frequent (90·4% of all participants), and included altered mood and insomnia. Changes to blood sugar levels and occurrence of blood clots in deep veins were more frequent for those people taking dexamethasone than the other two arms. There was no difference seen between the three arms, with no benefit seen over placebo with anorexia shown to improve in all 3 arms.