Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue
NCT ID: NCT06830018
Last Updated: 2025-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
76 participants
INTERVENTIONAL
2025-01-23
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy
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.
Standard Treatment
Standard Treatment，First-line treatment (chemotherapy + immunotherapy/targeted therapy)
Standard Therapy
Standard Treatment
Standard Treatment，First-line treatment (chemotherapy + immunotherapy/targeted therapy)
Interventions
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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.
Standard Treatment
Standard Treatment，First-line treatment (chemotherapy + immunotherapy/targeted therapy)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Hospital Of China Medical University
Shenyang, Liaoning, China
Countries
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Central Contacts
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Other Identifiers
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MGA- Fatigue-01
Identifier Type: -
Identifier Source: org_study_id
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