Clinical trial NCT03455205: Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Chemo Patients With Digestive Tract .
Official title: The Efficacy and Safety of Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Chemo Patients With Digestive Tract Were Prospectively, Randomized Blind, Multicenter Clinical Trials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Digestive Tract
Lead sponsor: Livzon Pharmaceutical Group Inc.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
First posted: 2018-03-06
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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, 7 days post, rest is 14 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

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 quality of life score changes and related laboratory index, evaluation factors ginseng and astragalus injection on the digestive tract tumor (chemotherapy) in patients with cancer-related fatigue and quality of life improved efficacy and safety. The experimental group was randomly divided into 2 groups, experimental group Shenqifuzheng injection of 500 ml. The control group was 0.9% sodium chloride injection, 500ml, intravenous drip, 1 time daily, 7 days for continuous use, 14 days of rest, and 1 treatment for each 21 days, and 2 courses were observed. At the same time, according to the NCCN guide and the health ministry issued the diagnosis and treatment guidelines for cancer treatment.

Main efficacy evaluation indexes before and after treatment for cancer-related fatigue rating - adopting the Piper fatigue scale revised Chinese version, compare the experimental group and the control group before and after treatment cancer-related fatigue rating difference have differences. Secondary efficacy evaluation index to compare the ECOG score difference before and after the treatment, the quality of life score difference before and after the treatment, TCM syndrome curative effect, single symptom curative effect of immune function, tumors had curative effect (if any) and chemotherapy completion. Safety assessment includes the observation of vital signs, blood routine, urinary routine, routine stool, liver function, renal function, electrocardiogram examination, and adverse reactions during the treatment.

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.

Primary outcomes:
measure: Piper Fatigue Scale（PFS）
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First affiliated hospital of guangzhou university of traditional Chinese medicine
state: Guangdong
Study officials:
affiliation: First affiliated hospital of guangzhou university of traditional Chinese medicine
name: lin lizhu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: