A phase II randomized trial of nano-crystalline megestrol acetate for nutritional improvement in postoperative head and neck squamous cell carcinoma undergoing radiotherapy.
Background: Head and neck squamous cell carcinoma (HNSCC) patients frequently experience malnutrition and weight loss, exacerbated by cancer cachexia and treatment-related side effects during concurrent radiotherapy. Nano-crystalline megestrol acetate (NMA) improves bioavailability and efficacy compared to conventional formulations, demonstrating enhanced appetite, weight gain, and quality of life (QoL) in cancer cachexia. Methods: This randomized, parallel-controlled Phase II trial evaluates the efficacy and safety of NMA in improving nutritional outcomes in HNSCC patients undergoing postoperative CCRT. The study enrolls 96 HNSCC post-surgery patients. Participants are stratified by pre-treatment weight loss (>5% vs. ≤5%) and standard treatment regimen (radiotherapy vs. concurrent chemoradiotherapy), then randomized 1:1 to receive NMA (625 mg/day) plus standard treatment or standard treatment alone. The novel aspects of this design include the use of a nano-crystalline formulation to overcome absorption challenges, allowing effective drug delivery in fasting states. Additionally, comprehensive endpoints assess appetite status (A/CS-12 score), weight changes, lean body mass, inflammatory and nutritional markers, and QoL, providing an integrated evaluation of nutritional and clinical benefits. 12 of planned 96 patients have been enrolled.
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