Status:
UNKNOWN
Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Chemo Patients With Digestive Tract .
Lead Sponsor:
Livzon Pharmaceutical Group Inc.
Collaborating Sponsors:
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Conditions:
Digestive Tract
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The efficacy and safety of cancer patients in patients with gastrointestinal cancer (chemotherapy) in patients with gastrointestinal tumor (chemotherapy) were prospectively, randomized blind, multicen...
Detailed Description
Factors for the purpose of this study by observing theShenqifuzheng injection before and after treatment in patients with carcinoma due to fatigue scale scores, the classification of syndromes, the qu...
Eligibility Criteria
Inclusion
- 1\. Patients with gastric cancer, esophageal cancer or colorectal cancer diagnosed by pathology or cytology;
- 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
- 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:
- clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, etc.
- uncontrolled hypertension (systolic pressure is greater than 160 mmHg or diastolic pressure is greater than 100 mmHg, despite the best drug treatment);
- serious clinical infection of activity (greater than 3 degrees NCI-CTCAE 4.03)
- 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.
Key Trial Info
Start Date :
December 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT03455205
Start Date
December 24 2017
End Date
December 30 2019
Last Update
March 6 2018
Active Locations (1)
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1
First affiliated hospital of guangzhou university of traditional Chinese medicine
Guangzhou, Guangdong, China