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

NCT07796789 | Recruiting Phase 3 DMC

• 1 other identifier: 2025-FXY-277
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Nasopharyngeal Cancinoma (NPC)

Keywords

Nasopharyngeal carcinoma; Nanocrystalline megestrol acetate; Anorexia; Weight loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 28 after completion of radiotherapy

Secondary Outcomes (9)

• Change From Baseline in FAACT-A/CS12 Score

  11 weeks

• Proportion of Patients With >5% Weight Loss From Baseline at the End of Radiotherapy

  7 weeks

• Percent Change in Body Weight From Baseline

  11 weeks

• Quality of life (QoL)

  11 weeks

• Quality of Life (QoL)

  11 weeks

Other Outcomes (2)

• Progression-free survival

  2 years

• Overall Survival

  2 years

Study Arms (2)

Nanocrystalline megestrol acetate group

EXPERIMENTAL

Nanocrystalline megestrol acetate + Concurrent chemoradiotherapy

Drug: Nanocrystalline Megestrol Acetate Oral Suspension

Placebo group

PLACEBO COMPARATOR

Placebo + Concurrent chemoradiotherapy

Drug: Placebo

Interventions

Nanocrystalline Megestrol Acetate Oral Suspension DRUG

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).

Nanocrystalline megestrol acetate group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (3)

Sun Yat-sen University Cancer Cente

Guangzhou, Guangdong, China

RECRUITING

Hunan Cancer Hospital

Changsha, China

NOT YET RECRUITING

Fujian Cancer Hospital

Fuzhou, China

NOT YET RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Anorexia; Weight Loss

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight

Central Study Contacts

Hai-Qiang Mai, PhD, MD

CONTACT

+8602087343643; maihq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Nasopharyngeal Carcinoma

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: September 1, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2029
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)