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Clinical Trials in China / NCT07796789
Recruiting Phase 3

Prophylactic Nanocrystalline Megestrol Acetate Versus Placebo for Chemoradiotherapy-Related Anorexia in Nasopharyngeal Carcinoma

NCT07796789 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 3
Started
2026-08-30
Last updated
2026-09-01

Condition(s) studied

Nasopharyngeal Cancinoma (NPC)

Investigational drug(s) / intervention(s)

Nanocrystalline Megestrol Acetate Oral SuspensionPlacebo

Nanocrystalline Megestrol Acetate Oral Suspension: 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: Placebo + Concurrent chemoradiotherapy: Placebo 5ml once daily orally (Week1-11) + Cisplatin 100mg/m\^2 (Day 1, 22, 43 during radiotherapy).

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Known allergy to any chemotherapeutic agent that may be used in the study. * Severe uncontrolled infection or other serious uncontrolled medical illness. * Major organ dysfunction, including decompensated cardiac, pulmonary, renal, or hepatic failure, that would preclude tolerance of chemoradiotherapy. * Conditions that may substantially affect drug administration, distribution, metabolism, or excretion, including significant psychiatric disorders, central nervous system disorders, chronic diarrhea, ascites, or pleural effusion. * Long-term use of immunosuppressive agents following organ transplantation. * History of another malignancy before enrollment. * Conditions affecting gastrointestinal absorption or oral intake, including dysphagia, malabsorption, or uncontrolled vomiting; difficulty with food intake or requirement for enteral or parenteral nutritional support; anorexia nervosa or anorexia related to psychiatric illness; or difficulty eating because of pain. * Current or planned use of other medications that may increase appetite or body weight, including systemic corticosteroids (except short-term dexamethasone administered during chemotherapy), androgens, progestogens, thalidomide, olanzapine, anamorelin, or other appetite stimulants. * Cushing syndrome, adrenal insufficiency, or pituitary insufficiency; poorly controlled diabetes mellitus; or uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite oral antihypertensive therapy. * Thromboembolic disease, ascites, or lower-extremity edema within 6 months before the first dose of study treatment; history of esophageal or gastric varices, severe gastrointestinal ulceration, gastrointestinal perforation and/or fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding. * Known hypersensitivity to any component of the study drug. * Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in the study.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Cente Guangzhou Guangdong Recruiting
Hunan Cancer Hospital Changsha China Not Yet Recruiting
Fujian Cancer Hospital Fuzhou China Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07796789 on ClinicalTrials.gov ↗ ← All trials in China