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

GeneScience Pharmaceuticals (GenSci)

Status

Enrolling

Conditions

Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment

Treatments

Combination Product: Standard Treatment

Drug: Nano-crystalline Megestrol Acetate Oral Suspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT06830018

MGA- Fatigue-01

Details and patient eligibility

About

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.

Enrollment

76 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.