Clinical trial NCT03413358: Clinical Trial for Post-marketing Evaluation of Sheng Bai Oral Liquid
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small-Cell Lung Cancer
Lead sponsor: BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Hubei Mon Yan Pharmaceutical Co., Ltd
First posted: 2018-01-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: These subjects will be randomized (1:1) to treatment group or control group.
Primary purpose: TREATMENT

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.

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 .

Eligibility 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.

Primary outcomes:
measure: The incidence and degree of neutropenia after chemotherapy
timeFrame: six weeks
measure: The recovery time of neutropenia
timeFrame: six weeks
Secondary outcomes:
measure: The incidence of neutropenia associated with Fever (FN) in patients after chemotherapy
timeFrame: six weeks
measure: The incidence of Peripheral blood thrombocytopenia disease
timeFrame: six weeks
measure: The duration of Peripheral blood thrombocytopenia disease
timeFrame: six weeks
measure: THE incidence and duration of hemoglobin reduction in peripheral blood
timeFrame: six weeks
measure: THE duration of hemoglobin reduction in peripheral blood
timeFrame: six weeks
measure: THE incidence and duration of peripheral blood leukocyte reduction
timeFrame: six weeks
measure: The duration of peripheral blood leukocyte reduction
timeFrame: six weeks
measure: The time when the neutrophils were reduced to the lowest point after chemotherapy
timeFrame: six weeks
measure: Neutrophil value of neutrophils in patients with low to lowest level after chemotherapy
timeFrame: six weeks
measure: MDASI-TCM
timeFrame: six weeks
measure: Cancer-related fatigue
timeFrame: six weeks
measure: rhG-CSF dosage
timeFrame: six weeks
measure: Immune Index (optional)
timeFrame: six weeks
Other outcomes:
measure: Genetic Testing
timeFrame: six weeks
Locations:
city: Beijing
country: China
facility: CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen Hospital
state: Beijing
Study officials:
affiliation: CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen Hospital
name: Hongsheng Lin, Professor
role: PRINCIPAL_INVESTIGATOR
References: