breast cancer
Conditions
Interventions
Probiotic group:Continuous oral administration of probiotics for 4 periods, 21 days per period
Placebo group:Continuous oral administration of Placebo for 4 periods, 21 days per period
Sponsors
Inner Mongolia Autonomous Region People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients who are pathologically confirmed to meet the diagnostic criteria for breast cancer, have undergone modified radical mastectomy, and are in TNM stage I-III, and are scheduled to receive AC chemotherapy; (2) There is no history of any type of organic mental illness, and there is no brain metastasis from breast cancer. (3) In general, it is possible, the ECOG score is at least 0 or 1, and the survival period is >6 months. (4) Aged between 18 and 65 years old. (5) No antidepressants or antipsychotic drugs were used within 2 weeks before enrollment. (6) Elementary school education or above, good communication skills, and able to read. (7) The functions of vital organs meet the following requirements (no blood components, cell growth factors, whitening drugs, platelet-raising drugs, and anemia-correcting drugs are allowed within 14 days before the first use of study drugs): Absolute neutrophil count (ANC) =1.5×109/L; platelets =100×109/L; hemoglobin =9g/dL; serum albumin =2.8g/dL; total bilirubin =1.5×ULN, ALT, AST and/or AKP =2.5×ULN ;Serum creatinine =1.5×ULN or creatinine clearance greater than 60mL/min;
Exclusion criteria
Exclusion criteria: (1) The subject requests to terminate study drug treatment; (2) If confirmed imaging disease progression occurs, the subject needs to terminate treatment, unless the subject meets the criteria for continuing treatment after progression; (3) A pregnancy event occurs in the subject during the research process; (4) Any clinical adverse events (AEs), laboratory test abnormalities, or other medical conditions occur, resulting in subjects who continue to take the drug may no longer benefit; (5) Overall deterioration of health condition and inability to continue participating in the trial; (6) The subject dies; (7) Subjects were lost to follow-up;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital Anxiety and Depression Scale;Gastrointestinal Symptom Rating Scale;Baker Depression Self-rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| gut microbiota; | — |
Countries
China
Contacts
Public ContactZhihui Cai
Inner Mongolia Autonomous Region People's Hospital
Outcome results
None listed