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

NCT03455205 | Unknown DMC

• 1 other identifier: livzon-sqfz-chemo
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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

Conditions

Digestive Tract

Outcome Measures

Primary Outcomes (1)

• Piper Fatigue Scale（PFS）

  the score of Piper Fatigue Scale before and after the treatment

  42 days

Study Arms (2)

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.

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'

Drug: 0.9%sodium chloride

Interventions

shenqifuzheng DRUG

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

shenqifuzheng injection

0.9%sodium chloride DRUG

500ml sodium chloride（0.9%）daily（at day 1-7 and day22-28）through intravenous infusion.

0.9% sodium chloride injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with gastric cancer, esophageal cancer or colorectal cancer diagnosed by pathology or cytology;
• Diagnostic criteria for cancer-related fatigue;
• \. Syndrome differentiation of Chinese medicine is a syndrome of lung temper;
• \. Estimated survival over 3 months;
• \. ECOG score is less than or equal to 2;
• \. Age 18 \~ 75 years old;
• \. Non-surgical indications or reluctance to operate the surgical treatment;
• \. Have chemotherapeutic indications;
• \. Stop and chemotherapy for more than 1 month;
• \. 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.

You may not qualify if:

• \. The chemotherapy regimen received by the subject was not within the prescribed programme;
• \. 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.
• \. Patients with symptoms, uncontrollable nerves, mental illness or mental disorders;
• \. Compliance.

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead
• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: collaborator

Study Sites (1)

First affiliated hospital of guangzhou university of traditional Chinese medicine

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• lin lizhu, Dr.

  First affiliated hospital of guangzhou university of traditional Chinese medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lin lizhu, Dr.

CONTACT

13501505588; 13501505588@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: March 6, 2018
• Study Start: December 24, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 6, 2018

Record last verified: 2017-12

Locations

CN (1)