Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT03455205
Eligibility Criteria:
Inclusion Criteria:
* 1\. Patients with gastric cancer, esophageal cancer or colorectal cancer diagnosed by pathology or cytology;
* 2.Diagnostic criteria for cancer-related fatigue;
* 3\. Syndrome differentiation of Chinese medicine is a syndrome of lung temper;
* 4\. Estimated survival over 3 months;
* 5\. ECOG score is less than or equal to 2;
* 6\. Age 18 \~ 75 years old;
* 7\. Non-surgical indications or reluctance to operate the surgical treatment;
* 8\. Have chemotherapeutic indications;
* 9\. Stop and chemotherapy for more than 1 month;
* 10\. The patient is willing to accept the treatment of the programme, and can follow the doctor's advice to take the medicine and comply with the patient.
Exclusion Criteria:
* 1\. The chemotherapy regimen received by the subject was not within the prescribed programme;
* 2\. Any situation that may hinder the subject from completing the clinical trial, including but not limited to serious, uncontrollable organic lesions or infection:
1. clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, etc.
2. uncontrolled hypertension (systolic pressure is greater than 160 mmHg or diastolic pressure is greater than 100 mmHg, despite the best drug treatment);
3. serious clinical infection of activity (greater than 3 degrees NCI-CTCAE 4.03)
4. severe liver and kidney function abnormality (blood creatinine is greater than 1.5 times ULN; ALT or AST is greater than 2.5 times ULN; Bilirubin is greater than 1.5 times ULN.
* 3\. Patients with symptoms, uncontrollable nerves, mental illness or mental disorders;
* 4\. Compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03455205
Study Brief:
Protocol Section:
NCT03455205