Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06830018

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

Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2025-02-17

76

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years to 75 years
  • Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2
  • Expected survival of at least 6 months
  • Diagnosis of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma or colorectal adenocarcinoma confirmed by histology or cytology
  • No prior systemic antitumor therapy for gastric/gastroesophageal junction adenocarcinoma or colorectal cancer
  • At least one measurable tumor lesion according to RECIST v1.1
  • Fatigue Visual Analog Scale (VAS) score of 4 or higher, indicating moderate or severe fatigue
  • Complaints of anorexia
  • Good organ function as determined by study requirements
Not Eligible

You will not qualify if you...

  • Significant surgery or traumatic injuries within the past 1 month
  • Conditions affecting gastrointestinal absorption such as dysphagia, malabsorption, or uncontrollable vomiting
  • Currently undergoing tube feeding or parenteral nutrition
  • Anorexia caused by neurosis, mental illness, or difficulty eating due to pain
  • Received erythropoietin or blood transfusion within the past 1 month
  • Serious cerebrovascular, heart, kidney, or liver diseases
  • History of hypersensitivity to components of the trial medication
  • Other conditions deemed inappropriate for study participation by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Hospital Of China Medical University

Shenyang, Liaoning, China, 110000

Actively Recruiting

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Research Team

X

Xiujuan Qu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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