Digestive TractNCT03455205
Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Chemo Patients With Digestive Tract .
A study testing shenqifuzheng and 0.9%sodium chloride in people with Digestive Tract, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Digestive Tract
- What is being tested?
- shenqifuzheng and 0.9%sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2017to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of guangzhou university of traditional Chinese medicine
Guangzhou, Guangdong
lin lizhu, Dr., 13501505588, 13501505588@163.com
About this study
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
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
Read the 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.
- Conditions
- Digestive Tract
- Being tested
- shenqifuzheng, 0.9%sodium chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shenqifuzhengDrug
500ml shenqifuzheng daily（at day 1-7and day22-28）through intravenous infusion.
0.9%sodium chlorideDrug
500ml sodium chloride（0.9%）daily（at day 1-7 and day22-28）through intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| shenqifuzheng injection | Experimental | 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. Receives: Drug: shenqifuzheng |
| 0.9% sodium chloride injection | Placebo comparator | 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' Receives: Drug: 0.9%sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Piper Fatigue Scale（PFS）
the score of Piper Fatigue Scale before and after the treatment
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start24 Dec 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive TractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- lin lizhu, Dr., Principal investigator, First affiliated hospital of guangzhou university of traditional Chinese medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455205
- Sponsor's protocol ID
- livzon-sqfz-chemo
- Status last verified
- Dec 2017
- First submitted
- 26 Dec 2017
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03455205
- Acronym / sponsor ID
- livzon-sqfz-chemo
- Conditions
- Digestive Tract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Study start
- 24 Dec 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shenqifuzheng injection | Experimental | Drug: shenqifuzhengShenqifuzheng 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. |
| 0.9% sodium chloride injection | Placebo comparator | Drug: 0.9%sodium chloride0.9% 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' |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (8 listed)
- 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:
- 3. Patients with symptoms, uncontrollable nerves, mental illness or mental disorders;
- 4. Compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shenqifuzheng500ml shenqifuzheng daily（at day 1-7and day22-28）through intravenous infusion. | Drug | shenqifuzheng injection |
| 0.9%sodium chloride500ml sodium chloride（0.9%）daily（at day 1-7 and day22-28）through intravenous infusion. | Drug | 0.9% sodium chloride injection |
Primary outcome
Piper Fatigue Scale（PFS）
Time frame: 42 days
the score of Piper Fatigue Scale before and after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lin lizhu, Dr. principal investigator
First affiliated hospital of guangzhou university of traditional Chinese medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shenqifuzheng and 0.9%sodium chloride in people with Digestive Tract, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lin lizhu, Dr. (13501505588, 13501505588@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Piper Fatigue Scale（PFS） (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.