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

Not Applicable

Recruiting

• Conditions: Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment
• Interventions: Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Combination Product: Standard Treatment

• Registration Number: NCT06830018
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-23
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Primary Completion: 2026-01
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy	Nano-crystalline Megestrol Acetate Oral Suspension	-
Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy	Standard Treatment	-
Standard Therapy	Standard Treatment	-

Primary Outcome Measures

Name	Time	Method
the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV).	week 6
the difference in improvement of appetite based on A/CS-12 assessment	week 6

Trial Locations

Locations (1)

The First Hospital Of China Medical University; 🇨🇳 Shenyang, Liaoning, China