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.
This phase III randomized, double-blind, placebo-controlled, multicenter trial compares the efficacy and safety of nanocrystalline megestrol acetate versus placebo in prevention and management of anorexia and weight loss associated with concurrent chemoradiotherapy (CCRT) in patients with locally advanced nasopharyngeal carcinoma (NPC). Eligible patients with newly diagnosed stage II-III NPC will be randomly assigned in a 1:1 ratio to receive either nanocrystalline megestrol acetate (5ml/day) or matching placebo for 11 weeks, in combination with standard CCRT. The study aims to evaluate whether nanocrystalline megestrol acetate can significantly reduce the proportion of patients experiencing clinically significant weight loss (\>5% from baseline) at day 28 post-radiotherapy, and to assess its impact on appetite, quality of life, nutritional status, and survival outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
Nanocrystalline 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 + Concurrent chemoradiotherapy: Placebo 5ml once daily orally (Week1-11) + Cisplatin 100mg/m\^2 (Day 1, 22, 43 during radiotherapy).
Sun Yat-sen University Cancer Cente
Guangzhou, Guangdong, China
RECRUITINGHunan Cancer Hospital
Changsha, China
NOT_YET_RECRUITINGFujian Cancer Hospital
Fuzhou, China
NOT_YET_RECRUITINGProportion 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.
Time frame: 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
Time frame: 11 weeks
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.
Time frame: 7 weeks
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%.
Time frame: 11 weeks
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.
Time frame: 11 weeks
Quality of Life (QoL)
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), version 3.0. Prespecified functional and symptom scale 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.
Time frame: 11 weeks
Skeletal Muscle Index at the Third Lumbar Vertebra (L3-SMI)
Change from baseline to the end of radiotherapy in skeletal muscle index at the third lumbar vertebra (L3-SMI) will be assessed using cross-sectional imaging. L3-SMI will be calculated as the skeletal muscle cross-sectional area at the L3 level normalized to height squared (cm²/m²) .
Time frame: 7 weeks
Proportion of Patients Receiving a Prespecified Cumulative Dose of Concurrent Cisplatin
The proportion of patients receiving a cumulative concurrent cisplatin dose of at least 200 mg/m² during radiotherapy and 3 cycles of concurrent cisplatin
Time frame: 7 weeks
Incidence of Acute Toxicity
The incidence and severity of acute adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The incidence of each adverse event will be reported separately.
Time frame: From the start of treatment to 90 days after completion of radiotherapy
Incidence of Late Radiation Toxicity
The incidence and severity of late radiation toxicities will be assessed according to the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) late radiation morbidity scoring scheme.
Time frame: 90 days after completion of radiotherapy to 2 years after completion of radiotherapy
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