breast cancer
Conditions
Interventions
Experimental group:Mecobalamin
Blank group:placebo
Sponsors
Sun Yat-Sen Memorial Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Women (aged 18-75) who were diagnosed with breast cancer for the first time and completed standard surgical treatment for breast cancer; 2. Patients with non metastatic breast cancer were prepared to receive capecitabine monotherapy or capecitabine combined with endocrine therapy and / or radiotherapy and / or targeted therapy. The dose of capecitabine was 1000mg / m2, bid 3. The score of ECoG was 0-1; 4. At random, the previous treatment-related toxicity should be reduced to NCI CTCAE (version 4.03) = 3.0 x 10^9 / L; ANC >= 1.5 x 10^9/L; PLT >=100 x 10^9/L; 6. The liver and kidney functions were normal within 4 weeks before admission (based on the normal values of laboratories in each research center): TBIL =60 ml/min; 7. Pregnant women of childbearing age must have a serum / urine pregnancy test in the first 4 weeks of enrollment, and the result is negative, and they are willing to use a medically recognized and effective contraceptive measure during the study period and within 6 months after the last administration of drugs; 8. Informed consent has been signed before joining the group; 9. No active infectious diseases within 12 weeks after screening.
Exclusion criteria
Exclusion criteria: 1. Metastatic breast cancer (chest wall, lung, bone, liver) indicated by imaging or pathology; 2. Uncontrolled pleural effusion, pericardial effusion and ascites; 3. Uncontrollable tumor related pain; 4. There was a history of malignancy other than breast cancer within the first 5 years of randomization, but the risk of metastasis or death was negligible, and except for the malignant tumors which can be cured after treatment (such as cervical carcinoma in situ and non melanoma skin which have been properly treatedCancer or stage I uterine cancer); 5. May interfere with the accompanying diseases or conditions of the study, or have any serious medical barriers that may affect the safety of the subjects obstruction (e.g., uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection); 6. With any disease affecting skin conditions: diabetes, dermatomyositis, sclerosis, lupus erythematosus, etc.; 7. Known history of psychoactive substance abuse or drug use; 8. Pregnant or nursing patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of hand foot syndrome above grade 2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset time of HFS above grade 2;Severity of HFS;Quality of life scale;Disease-free survival;Adverse Events; | — |
Countries
China
Contacts
Public ContactErwei Song
Sun Yat-Sen Memorial Hospital
Outcome results
None listed