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Recruiting NCT06830018

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

No phase Interventional Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nano-crystalline Megestrol Acetate Oral Suspension, Standard Treatment.
Who it may be relevant to
Registry conditions: Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

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.

Interventions

  • Drug Nano-crystalline Megestrol Acetate Oral Suspension
    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.
  • Combination product Standard Treatment
    Standard Treatment，First-line treatment (chemotherapy + immunotherapy/targeted therapy)

Primary outcome measures

  • 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 [Time frame: week 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

China · 1 center
  • The First Hospital Of China Medical University — Shenyang

Identifiers

NCT: NCT06830018 · MGA- Fatigue-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗