RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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)

Locations (1)

The First Hospital Of China Medical University

Shenyang, Liaoning, China