Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue
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
Changchun GeneScience Pharmaceutical Co., Ltd.
76 participants
Jan 23, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 Criteria8
- 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.
Interventions
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，First-line treatment (chemotherapy + immunotherapy/targeted therapy)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06830018