Carcinogenic Fatigue Clinical Trial
Official title:
The Efficacy and Safety of Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Patients(Palliative Care) With Digestive Tract Were Prospectively, Randomized Blind, Multicenter Clinical Trials
The efficacy and safety of cancer patients in patients with gastrointestinal cancer (Palliative care) in patients with gastrointestinal tumor (chemotherapy) were prospectively, randomized blind, multicenter clinical trials. They were randomly divided into 2 groups, test group Shenqifuzheng injection of 500 ml, the control group 0.9% sodium chloride injection, 500 ml, intravenous drip, 1 times a day, 14 days post, rest is 7 days, 21 days each for a period of treatment, observation of two procedures. At the same time, according to the NCCN guide and the health ministry issued the diagnosis and treatment guidelines for cancer treatment. The main curative effect of the clinic was to evaluate the pretreatment of cancer due to the fatigue score of the patients before and after treatment -- the Piper fatigue revision scale was used to evaluate the Chinese version. Assess effectiveness and safety based on clinical assessment
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | December 30, 2019 |
| Est. primary completion date | December 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 3 - 6. Age 18 ~ 80 years old; - 7. Non-surgical indications or reluctance to operate the surgical treatment; - 8. 70 g/L or higher HGB; - 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. Any situation that may hinder the subject from completing the clinical trial, including but not limited to serious, uncontrollable organic disease or infection: 1. clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, etc. 2. serious clinical infection of activity (greater than 3 degrees nci-ctcae 4.03) 3. uncontrolled hypertension (systolic pressure is greater than 160 mmHg or diastolic pressure is greater than 100 mmHg, despite the best drug treatment); 4. severe liver and kidney function abnormality (blood creatinine is greater than 1.5 times ULN; ALT or AST is greater than 5 times ULN; Bilirubin is greater than 1.5 times ULN. 5. other diseases that need to be controlled: pulmonary congestion, etc. - 2. Patients with symptoms, uncontrollable nerves, mental illness or mental disorders; - 3. Compliance. |
| Country | Name | City | State |
|---|---|---|---|
| China | First affiliated hospital of guangzhou university of traditional Chinese medicine | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Livzon Pharmaceutical Group Inc. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Piper Fatigue Scale(PFS) | Change From Baseline in Piper Fatigue Scores at 42 days | 42 days |