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.
Prior antitumor therapy, including chemotherapy, radiotherapy, or surgery, other than induction chemotherapy permitted according to the study protocol.
Pregnant or breastfeeding women.
Inability to comply with regular follow-up because of psychological, social, familial, or geographical factors.
Concurrent participation in another clinical study involving investigational treatment during the study treatment period.
Parallel
Nanocrystalline Megestrol Acetate Oral Suspension
DrugNanocrystalline megestrol acetate + Concurrent chemoradiotherapy: Nanocrystalline megestrol acetate oral suspension 625 mg (5ml) once daily orally (Week1-11) + Cisplatin 100mg/m\^2 (Day 1, 22, 43 during radiotherapy).
Placebo
DrugPlacebo + Concurrent chemoradiotherapy: Placebo 5ml once daily orally (Week1-11) + Cisplatin 100mg/m\^2 (Day 1, 22, 43 during radiotherapy).
Proportion of Patients With >5% Weight Loss From Baseline at Day 28 After Completion of Radiotherapy
The proportion of patients who experience more than 5% body weight loss compared with baseline body weight, assessed at Day 28 after completion of radiotherapy.
Change From Baseline in FAACT-A/CS12 Score
Change from baseline in anorexia/cachexia-related symptoms will be assessed using the Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale (FAACT-A/CS12) to week 4, end of radiotherapy, and Day 28 after completion of radiotherapy
Proportion of Patients With >5% Weight Loss From Baseline at the End of Radiotherapy
The proportion of patients with a decrease in body weight of more than 5% from baseline body weight at the end of radiotherapy.
Percent Change in Body Weight From Baseline
Percentage change in body weight from baseline to the end of radiotherapy and day 28 after completion of radiotherapy will be calculated as \[(body weight at the prespecified assessment - baseline body weight) / baseline body weight\] × 100%.
Quality of life (QoL)
assessed using the EORTC Quality of Life Questionnaire Head and Neck Cancer Module (EORTC QLQ-H\&N35), version 1.0. Prespecified symptom scale and item scores will be calculated according to the EORTC scoring manual at baseline, week 4 of radiotherapy, end of radiotherapy, and day 28 after completion of radiotherapy.
Progression-free survival
The time from randomization to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occur first.
Overall Survival
Overall survival is defined as the time from randomization to death from any cause.
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