Breast cancer
Conditions
Interventions
Experimental Group:Sodium monosialoganglioside + albumin-bound paclitaxel chemotherapy regimen
Chinese Medicines Group:Chinese herbal fumigation + albumin-bound paclitaxel chemotherapy regimen
Joint Group:Chinese herbal fumigation + sodium monosialoganglioside + albumin-bound paclitaxel chemotherapy regimen
Control Group:Saline + albumin-bound paclitaxel chemotherapy regimen
Sponsors
The Second Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Female patients with histologically confirmed breast cancer; 2.Age >=18 years and =3 months; 6.The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, no use of leukocyte or platelet-rising drugs); Complete blood count: neutrophil (ANC) >=1.5x10^9/L; Platelets (PLT) >=90x10^9/L; Hemoglobin (Hb) >=90g/L; Blood biochemical total bilirubin (TBIL) <=1.5xULN; Alanine aminotransferol (AST) and aspartate nitrogen transferase (AST) not exceeding 2xULN; Blood urea nitrogen (BUN) and creatinine (CR) less than 1.5xULN; 7.The FACT-Ntx score during the screening period was 44 points; 8.Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Any toxic event in the peripheral nervous system prior to enrollment, including: FACT-Ntx subscale score 1; 4. Pregnant or lactating women; 5. Patients who also have other neurological abnormalities and cannot accurately record the occurrence and severity of neurotoxicity; 6. Patient has known allergy to the test drug or excipient components of these products; 7. Patients with diabetes mellitus or hereditary glucose and lipid metabolism abnormalities (gangliopathy, such as triad familial idiopathic and retinopathy); 8. Patients who are not suitable for ganglioside therapy; 9. Patients with severe intercurrent illness that may jeopardize safety and interfere with scheduled treatment, or comorbid disease that may affect the completion of the study, depending on the judgment of the investigator; 10. Patients with a clear history of neurological or psychiatric abnormalities, including epilepsy or dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FACT-Ntx scale neurotoxicity score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Common Terminology Criteria for Adverse Events; | — |
Countries
China
Contacts
Public ContactXingchao Xu
The Second Affiliated Hospital of Shandong First Medical University
Outcome results
None listed