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

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.

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.