NCT06830018

Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue

A Multicenter, Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment Alone for the First-line Treatment of Patients With Cancer-related Fatigue In Gastric Or Colorectal Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for the first-line treatment of patients with cancer-related fatigue in gastric or colorectal cancer.

Conditions

• Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment

Interventions

Type	Name	Description
DRUG	Nano-crystalline Megestrol Acetate Oral Suspension	Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day), and continues medication; after completing the treatment cycle, patients who are assessed by the researchers as suitable for continued treatment may continue to receive therapy.
COMBINATION_PRODUCT	Standard Treatment	Standard Treatment，First-line treatment (chemotherapy + immunotherapy/targeted therapy)

Timeline

• Start date: 2025-01-23
• Primary completion: 2026-01-01
• Completion: 2026-07-01
• First posted: 2025-02-17
• Last updated: 2025-02-17

Locations

1 site across 1 country: China