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Clinical Trial for Post-marketing Evaluation of Sheng Bai Oral Liquid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03413358
Recruitment Status : Unknown
Verified January 2018 by BeiJing Yijiayi Medicine Techonoloy Co., Ltd..
Recruitment status was:  Recruiting
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
Hubei Mon Yan Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.

Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of Sheng Bai oral liquid in prevention and treatment of the decrease of neutrophilics after chemotherapy in patients with non-small-cell lung cancer.

Condition or disease Intervention/treatment Phase
Non-small-Cell Lung Cancer Drug: Sheng Bai oral liquid Drug: Platinum-based two medicine (carboplatin / cisplatin) . Not Applicable

Detailed Description:
The Clinical trail is a multicenter, prospective, randomized controlled study. The planned sample size is 240 subjects. These subjects will be randomized (1:1) to treatment group (Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid) or control group ( Platinum-based two medicine (carboplatin / cisplatin) plus blank control). The study population includes the patients with non-small-cell lung cancer .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: These subjects will be randomized (1:1) to treatment group or control group.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Sheng Bai Oral Liquid in Prevention and Treatment for The Decrease of Neutrophils After Chemotherapy in Patients With Non-Small-Cell Lung Cancer
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin

Arm Intervention/treatment
Experimental: Treatment group
Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid.
Drug: Sheng Bai oral liquid

Drug: Sheng Bai oral liquid 40 mL, oral use, thrice daily after screening on the same day in the second course of the chemotherapy.

Subjects will be treated for 2 courses


Drug: Platinum-based two medicine (carboplatin / cisplatin) .
Using Platinum-based two medicine (carboplatin / cisplatin)

Experimental: Control group
Blank control and Platinum-based two medicine (carboplatin / cisplatin) .
Drug: Platinum-based two medicine (carboplatin / cisplatin) .
Using Platinum-based two medicine (carboplatin / cisplatin)




Primary Outcome Measures :
  1. The incidence and degree of neutropenia after chemotherapy [ Time Frame: six weeks ]
    Comparison of the incidence and extent of neutrophil reduction in two chemotherapy cycles between two groupschemotherapy cycles between two groups according to CTC AE4.03,as well as the recovery time of neutropenia

  2. The recovery time of neutropenia [ Time Frame: six weeks ]
    Comparison of the recovery time between two groups of Polymorphonuclear neutropenia


Secondary Outcome Measures :
  1. The incidence of neutropenia associated with Fever (FN) in patients after chemotherapy [ Time Frame: six weeks ]
    Comparison of the incidence of fever with neutropenia in two chemotherapy cycles between two groups.

  2. The incidence of Peripheral blood thrombocytopenia disease [ Time Frame: six weeks ]
    Comparison of the incidence and duration of thrombocytopenia in two chemotherapy cycles between the two groups according to CTC AE4.03.

  3. The duration of Peripheral blood thrombocytopenia disease [ Time Frame: six weeks ]
    Comparison of the incidence and duration of thrombocytopenia in two chemotherapy cycles between the two groups according to CTC AE4.03.

  4. THE incidence and duration of hemoglobin reduction in peripheral blood [ Time Frame: six weeks ]
    Comparison of the incidence and duration of haemoglobin reduction in two chemotherapy cycles between two groups according to CTC AE4.03.

  5. THE duration of hemoglobin reduction in peripheral blood [ Time Frame: six weeks ]
    Comparison of the incidence and duration of haemoglobin reduction in two chemotherapy cycles between two groups according to CTC AE4.03.

  6. THE incidence and duration of peripheral blood leukocyte reduction [ Time Frame: six weeks ]
    Comparison of the incidence and duration of leukopenia in two chemotherapy cycles between the two groups according to CTC AE4.03.

  7. The duration of peripheral blood leukocyte reduction [ Time Frame: six weeks ]
    Comparison of the incidence and duration of leukopenia in two chemotherapy cycles between the two groups according to CTC AE4.03.

  8. The time when the neutrophils were reduced to the lowest point after chemotherapy [ Time Frame: six weeks ]
    Comparison of the time when the neutrophils were reduced to the lowest point after chemotherapy in two chemotherapy cycles between the two groups.

  9. Neutrophil value of neutrophils in patients with low to lowest level after chemotherapy [ Time Frame: six weeks ]
    Comparison of neutrophil values between two groups when neutrophils were reduced to the lowest point after chemotherapy

  10. MDASI-TCM [ Time Frame: six weeks ]
    Comparison of the TCM syndrome score changes between two groups before and after treatment.(if you want see the scale information ,you can reference to the link:https://www.mdanderson.org/content/dam/mdanderson/documents/Departments-and-Divisions/Symptom-Research/MDASI-TCM_SAMPLE.pdf)

  11. Cancer-related fatigue [ Time Frame: six weeks ]
    Comparison of the degree of fatigue changes between two groups before and after treatment.

  12. rhG-CSF dosage [ Time Frame: six weeks ]
    Comparison of the rhG-CSF dosage between two groups before and after treatment.

  13. Immune Index (optional) [ Time Frame: six weeks ]
    Observed indicators include IL-2, INF, NK cells, CD4 +, CD8 +, divided according to the results increased(After treatment than before treatment to improve ≥ 10%, or returned to normal by the abnormalities), decreased(After treatment than before treatment decreased ≥ 10%, or from normal to abnormal changes), stable(After treatment than before treatment, decreased less than 10% or maintained within the normal range).


Other Outcome Measures:
  1. Genetic Testing [ Time Frame: six weeks ]
    The changes of body index before and after treatment were compared between two groups of subjects.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who are confirmed no small cell lung cancer in accordance with the clinical diagnostic criteria , or by pathological histology or cytology examination which investigators think are suitable to accept The platinum-based doublet chemotherapy(According to RECIST V1.1,patients with no small cell cancers should have one measurable lesions at least ).
  2. ECOG performance status ≤2.
  3. Laboratory inspection basically meets the following requirements: 1)Blood test:a. WBC≥ 4.0×109/L, b. ANC≥2.0×109/L, c. PLT≥100×109/L. 2)Biochemical test:a. ALT≤2.5 times the ULN;b. AST≤2.5 times the ULN ;c. Cr<=1.5 times the ULN.
  4. Expected survival period is more than 3 months
  5. Subjects join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.

Exclusion Criteria:

  1. Patients need radiotherapy, targeted therapy, and other anti-cancer therapies during the trial.
  2. Patients accepted radiation in the past 4 weeks before enrollment.
  3. Previous bone marrow or stem cell transplant, or organ allograft.
  4. Recently severe acute infection is not controlled; purulent or chronic infection is present and the wound is not healed.
  5. Patients were or being suspected to be allergic to test drugs or related components.
  6. Patients with hypersplenism, hyperthyroidism, adrenal cortical hypofunction, connective tissue disease, infectious diseases, such as viral hepatitis, tuberculosis infection and other diseases which can lead to the decrease of the white blood cells at the same time.
  7. Patients with the symptoms of digestive system, such as nausea, vomiting, diarrhea, etc., that are not controlled will influence the test drug.
  8. The central nervous system is metastatic and has symptoms.
  9. History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma.
  10. Patients with severe heart, liver and kidney diseases; serious diseases of hematopoietic system; bleeding tendency.
  11. Patients have a history of drug abuse and cannot be reined ;Patients with symptomatic, uncontrolled nervous disorders, mental illness or psychiatric disorder have less compliance.
  12. Female patient is pregnant or breast-feeding, and those patients at childbearing age who are not willing to use methods of contraception.
  13. Patients who are currently included in other clinical trials or accepted any experimental drugs in the past 4 weeks.
  14. Any condition, in the investigator's opinion, is not in the best interest of the subject.

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): NCT03413358


Contacts
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Contact: Hongsheng Lin, Professor 010-88001192 drlinhongsheng@163.com

Locations
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China, Beijing
CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen Hospital Recruiting
Beijing, Beijing, China, 100053
Contact: Hongsheng Lin, Professor    010-88001192    drlinhongsheng@163.com   
Contact: Professor         
Sponsors and Collaborators
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
Hubei Mon Yan Pharmaceutical Co., Ltd
Investigators
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Principal Investigator: Hongsheng Lin, Professor CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen Hospital

Additional Information:
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Responsible Party: BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
ClinicalTrials.gov Identifier: NCT03413358    
Other Study ID Numbers: 2017-133-KY-01
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

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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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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Antineoplastic Agents