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

NCT07796789 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-09-01

No results posted yet for this 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.

Conditions

  • Nasopharyngeal Cancinoma (NPC)

Interventions

DRUG

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).

DRUG

Placebo

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-30
Primary Completion
2027-08-30
Completion
2029-08-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07796789 on ClinicalTrials.gov