Using nano-crystalline megestrol to treat cancer-related fatigue in advanced gastric or colorectal cancer
Official title: 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
Run by Changchun GeneScience Pharmaceutical Co., Ltd. · NCT06830018 · Data updated 2026-11-12
This study is testing if a new form of megestrol can help people with advanced gastric or colorectal cancer feel less tired when combined with their usual treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shenyang, Liaoning) |
| Status | Recruiting |
| Started | January 23, 2025 |
| Main results expected | January 2026 |
| Study ends | July 2026 |
| Registry record updated | February 17, 2025 |
| Trial ID | NCT06830018 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 75 with advanced gastric or colorectal cancer experiencing moderate to severe cancer-related fatigue.
✕Probably not a fit
Patients who have undergone significant surgery recently or have conditions affecting gastrointestinal absorption may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness and safety of nano-crystalline megestrol acetate when combined with standard treatment for patients suffering from cancer-related fatigue due to advanced gastric or colorectal cancer. It is a prospective, randomized, parallel-controlled trial that aims to compare the outcomes of patients receiving the combination treatment against those receiving standard treatment alone. Participants must meet specific eligibility criteria, including age, cancer type, and fatigue levels, to ensure a focused assessment of the treatment's impact.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate cancer-related fatigue, improving the quality of life for patients with advanced gastric or colorectal cancer.
How similar studies have gone: While there is ongoing research in cancer-related fatigue treatments, the specific use of nano-crystalline megestrol acetate in this context is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years and ≤75 years. * Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2. * Expected survival ≥ 6 months. * Locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal adenocarcinoma not amenable to radical treatment with histologic or cytologic confirmation. * No prior systemic systemic antitumor therapy for gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal cancer. * Have at least one measurable tumor lesion according to RECIST v1.1. * Compliance with a Fatigue Visual Analog Scale (VAS) score of ≥ 4 (consistent with moderate or severe fatigue). * Complain of anorexia. * Good organ function as determined by the following requirements. Exclusion Criteria: * Suffered significant surgery or traumatic injuries within the past 1month. * Having any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrollable vomiting. currently undergoing tube feeding or parenteral nutrition. * Suffering from anorexia due to neurosis, mental illness, or difficulty eating due to pain. * Received erythropoietin or blood transfusion within the past 1month. * Comorbidities such as serious cerebrovascular, heart, kidney, or liver disease. * A history of hypersensitivity to the components of the trial medication. * Other conditions that were considered inappropriate as determined by the investigators.
Where it's running
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The First Hospital Of China Medical University
Shenyang, Liaoning, China Recruiting
Study contacts
- Study coordinator: Xiujuan Qu
- Email: xjqu@cmu.edu.cn
- Phone: 024-83281560
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.