Prophylactic Nanocrystalline Megestrol Acetate Versus Placebo for the Management of Concurrent Chemoradiotherapy-related Anorexia in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: a Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial
This phase III randomized, double-blind, placebo-controlled trial evaluates whether nanocrystalline megestrol acetate can reduce anorexia in patients with locally advanced nasopharyngeal carcinoma (NPC) undergoing concurrent chemoradiotherapy (CCRT). The study aims to confirm the clinical benefits of adding this agent to standard CCRT for improving appetite, quality of life, nutritional status, and survival outcomes.
• Newly diagnosed, histologically or cytologically confirmed non-keratinizing nasopharyngeal carcinoma, clinical stage II-III according to the American Joint Committee on Cancer (AJCC) 9th edition staging system, and planned to receive concurrent chemoradiotherapy (CCRT).
• No prior radiotherapy to the primary tumor.
• Induction chemotherapy may be administered at the investigator's discretion according to local guidelines.
• Aged 18-70 years, male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Able to comply with the study procedures and voluntarily provide written informed consent.
• Adequate organ function, defined as follows:
‣ Hematologic function: neutrophil count ≥1.5 × 10⁹/L, hemoglobin ≥90 g/L, and platelet count ≥100 × 10⁹/L.
⁃ Coagulation function: international normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) ≤1.5 × the upper limit of normal (ULN).
⁃ Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN, total bilirubin ≤2.0 × ULN, and serum albumin ≥30 g/L.
⁃ Renal function: serum creatinine ≤1.5 × ULN or calculated creatinine clearance (CrCl) ≥60 mL/min using the Cockcroft-Gault formula.