Role of megestrol acetate during concurrent chemoradiotherapy for locally advanced head and neck cancer patients: a randomized trial

Background: Locally advanced head and neck cancer (HNC) treated with concurrent chemo-radiotherapy (CRT) often leads to severe weight loss due to treatment-induced toxicities such as mucositis and dysphagia. This study evaluated the efficacy of megestrol acetate (MA) in limiting weight loss and reducing acute toxicities in HNC patients undergoing CRT. Materials and methods : In this randomized controlled trial, 60 patients with carcinoma of the oropharynx, larynx, or hypopharynx were randomized (1:1) to receive oral MA (160 mg/day) with CRT or CRT alone. Nutritional status was assessed using weight, body mass index (BMI), and mid-upper arm circumference (MUAC). Acute toxicities were graded per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Results : Baseline characteristics were well balanced between the groups. No statistically significant difference was observed in mean weight loss between the MA and control groups (5.09 ± 2.08 kg vs . 5.32 ± 0.96 kg; p = 0.972). Reductions in BMI (p = 0.774) and MUAC (p = 0.788) were also similar. There were no significant differences in the incidence of grade 3 mucositis [16 (53.3%) vs . 15 (50.0%) patients; p = 0.796] or grade 3 dysphagia [13 (43.3%) vs . 14 (46.7%) patients; p = 0.795]. MA was well tolerated with no drug-related adverse events. Conclusions : The addition of low-dose MA (160 mg/day) did not significantly prevent weight loss or reduce acute toxicities in HNC patients undergoing CRT. Mechanical barriers like severe mucositis and dysphagia may override the appetite-stimulating effects of MA in this population.