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

February 27, 2018 updated by: Livzon Pharmaceutical Group Inc.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Piper Fatigue Scale（PFS）
Time Frame: 42 days
the score of Piper Fatigue Scale before and after the treatment
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Livzon Pharmaceutical Group Inc.

Collaborators

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: lin lizhu, Dr., First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2017

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

December 26, 2017

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

March 6, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • livzon-sqfz-chemo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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