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NCT Number: NCT06830018

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital Of China Medical University

Shenyang, Liaoning, 110000, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nano-crystalline Megestrol Acetate Oral Suspension

Drug

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.

Standard Treatment

Combination Product

Standard Treatment,First-line treatment (chemotherapy + immunotherapy/targeted therapy)

Primary outcomes

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

    Time frame: week 6

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

    Time frame: week 6

Study contacts

Contact information is provided by the study sponsor or research team.

Xiujuan Qu

CONTACT

[email protected]

024-83281560

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.