Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
The First Hospital Of China Medical University
Shenyang, Liaoning, China, 110000
Actively Recruiting
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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