RecruitingNot ApplicableNCT06830018

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

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Enrollment

76 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new formulation of megestrol (a hormone medication that can stimulate appetite and reduce fatigue) alongside standard first-line chemotherapy for people with advanced stomach or colorectal cancer who are experiencing cancer-related fatigue. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced (locally advanced or metastatic) gastric, gastroesophageal junction, or colorectal adenocarcinoma confirmed by biopsy - You have not yet received any chemotherapy for this cancer - You have at least one measurable tumor on scans - You have significant cancer-related fatigue (scoring at or above a defined threshold on a fatigue scale) - Your expected survival is at least 6 months - You are in reasonably good physical condition (ECOG score 0–2) **You may NOT be eligible if...** - You have already received prior systemic treatment for this cancer - You have significant heart, liver, or kidney problems - You have a history of blood clots (megestrol can increase clot risk) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNano-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_PRODUCTStandard Treatment

Standard Treatment，First-line treatment (chemotherapy + immunotherapy/targeted therapy)

Locations(1)

The First Hospital Of China Medical University

Shenyang, Liaoning, China

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NCT06830018