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Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Chemo Patients With Digestive Tract .

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ClinicalTrials.gov Identifier: NCT03455205
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Livzon Pharmaceutical Group Inc.

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

Condition or disease Intervention/treatment Phase
Digestive Tract Drug: shenqifuzheng Drug: 0.9%sodium chloride Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 24, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: shenqifuzheng injection

Shenqifuzheng injection of 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 programme provides for chemotherapy regimens:

Colorectal cancer: CapeOX scheme - oxaliplatin + capecitabine Esophageal cancer: DP/TP programme - docetaxel/paclitaxel + cisplatin/carboplatin Gastric cancer: SOX scheme - oxaliplatin + tigio All test drugs should be covered with dark bags before infusion, and use a dark infusion to guarantee the implementation of the blind method.

Drug: shenqifuzheng
500ml shenqifuzheng daily(at day 1-7and day22-28)through intravenous infusion.

Placebo Comparator: 0.9% sodium chloride injection
0.9% sodium chloride injection of 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 programme provides for chemotherapy regimens: Colorectal cancer: CapeOX scheme - oxaliplatin + capecitabine Esophageal cancer: DP/TP programme - docetaxel/paclitaxel + cisplatin/carboplatin Gastric cancer: SOX scheme - oxaliplatin + tigio No interventions have been included in Arm Description for '0.9% sodium chloride injection'
Drug: 0.9%sodium chloride
500ml sodium chloride(0.9%)daily(at day 1-7 and day22-28)through intravenous infusion.




Primary Outcome Measures :
  1. Piper Fatigue Scale(PFS) [ Time Frame: 42 days ]
    the score of Piper Fatigue Scale before and after the treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455205


Contacts
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Contact: lin lizhu, Dr. 13501505588 13501505588@139.com

Locations
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China, Guangdong
First affiliated hospital of guangzhou university of traditional Chinese medicine Recruiting
Guangzhou, Guangdong, China
Contact: lin lizhu, Dr.    13501505588    13501505588@163.com   
Sponsors and Collaborators
Livzon Pharmaceutical Group Inc.
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Investigators
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Principal Investigator: lin lizhu, Dr. First affiliated hospital of guangzhou university of traditional Chinese medicine

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Responsible Party: Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier: NCT03455205     History of Changes
Other Study ID Numbers: livzon-sqfz-chemo
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms