Leukopenia after chemotherapy for gastric cancer, colorectal cancer, ovarian cancer and lymphoma
Conditions
Interventions
Experimental group:Start taking Aiyu Capsules orally 3 days before chemotherapy
Sponsors
The First Affiliated Hospital of Guizhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 (including threshold), male or female; 2. Patients diagnosed with stage ? - ? gastric cancer, colorectal cancer, ovarian cancer and lymphoma by histopathology and prepared for chemotherapy with normal WBC test values; 3. Weight =45kg; 4. Expected to receive standard chemotherapy regimen: XELOX regimen for gastric cancer, XELOX regimen for colorectal cancer, platinum + paclitaxel regimen for ovarian cancer, and CHOP regimen for lymphoma; 5.ECOG score 0 or 1; 6. Expected survival =3 months; 7. Suitable organ and hematopoietic function, liver function: serum total bilirubin (TBIL) = 1.5×ULN, alanine aminotransferase (ALT) and alanine aminotransferase (AST) = 1.5×ULN; ALT and AST= 2.5×ULN in patients with liver metastasis; Renal function: serum creatinine (Cr) = 1.5×ULN or creatinine clearance (CCr) =50 mL/min; Hematopoietic function of bone marrow was normal without bleeding tendency (INR<1.5). 8. Normal or abnormal ecg results have no clinical significance; 9. Subjects voluntarily participate and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. History of other malignant tumors (radical radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resected carcinoma in situ, etc., which had been cured for more than 5 years, were eligible for inclusion); 2. Have primary hematologic diseases, including but not limited to myelodysplastic syndrome, aplastic anemia, sickle cell anemia and other hematologic diseases affecting the hematopoietic function of bone marrow; 3. Patients with known CNS metastasis or suspected CNS metastasis based on clinical manifestations; 4. Previous bone marrow transplantation and/or stem cell transplantation; 5. Current uncontrolled infection or systematic anti-infective therapy within the first 72 hours of randomization; 6. Patients with severe liver and kidney dysfunction; 7. A history of serious heart disease, including, but not limited to: congestive heart failure (NYHA Class II heart disease or above); Unstable angina that requires the use of antiangina drugs; Uncontrolled hypertension (systolic blood pressure =180 mmHg and/or diastolic blood pressure =100 mmHg); Arrhythmias requiring medical treatment; 8. Known to have severe diabetes (such as fundus lesions or diabetic foot complications), or poor blood glucose control after active treatment; 9. Active hepatitis B (hbSAG positive and hbV-DNA copy number greater than the upper limit of normal) and/or active hepatitis C (HCV antibody positive and HCV-RNA copy number greater than the upper limit of normal) and/or human immunodeficiency virus antibody positive subjects; 10. Those who have allergic diseases or allergies or have been allergic to any of the drugs or their components in the test; 11. Participated in clinical trials of any other drugs within 4 weeks prior to enrollment; 12. Cases deemed unsuitable for inclusion by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The extent, incidence and duration of leukopenia and neutrophil reduction after chemotherapy.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The amplitude, incidence, and duration of leukopenia and neutrophil reduction in the next cycle of chemotherapy after therapeutic administration;Granulocyte colony-stimulating factor usage;The quality of life;TCM syndrome improvement;Safety; | — |
Countries
China
Contacts
Public ContactDongxin Tang
The First Affiliated Hospital of Guizhou University of Chinese Medicine
Outcome results
None listed