Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue
Recruiting · NCT06830018 · Interventional (participants receive a specific treatment) · Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Nano-crystalline Megestrol Acetate Oral SuspensionStandard Treatment
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- The First Hospital Of China Medical University - Shenyang, Liaoning, China