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RECRUITING
NCT07796789
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: Prophylactic Nanocrystalline Megestrol Acetate Versus Placebo for the Management of Concurrent Chemoradiotherapy-related Anorexia in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: a Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2026-08-30

Completion Date

2029-08-30

Last Updated

2026-09-01

Healthy Volunteers

No

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).

Locations (3)

Sun Yat-sen University Cancer Cente

Guangzhou, Guangdong, China

Hunan Cancer Hospital

Changsha, China

Fujian Cancer Hospital

Fuzhou, China