Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue

Changchun GeneScience Pharmaceutical Co., Ltd.76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV).

Time frame: week 6

the difference in improvement of appetite based on A/CS-12 assessment