Breast cancer
Conditions
Interventions
Experimental group1:Thalidomide
Experimental group2:Probiotics
Experimental group3:Combination
Sponsors
The Sixth Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18 to 70 years; 2. According to the 2020 edition of "Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines", eligible for chemotherapy; 3. Use a treatment plan containing paclitaxel, with diarrhea grades above G2; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1; 5. Provide written informed consent; 6. During the active monitoring phase of the study, willing to return to the registry for follow-up; 7. Willing to provide necessary tumor tissue and/or blood samples for relevant research; 8. Willingness to check gastrointestinal function and provide analysis of fecal flora.
Exclusion criteria
Exclusion criteria: 1. Patients who cannot tolerate chemotherapy; 2. Patients who are unable to swallow oral medications or have impaired gastrointestinal (GI) function or gastrointestinal disease that may significantly alter drug absorption (eg, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndromes) symptoms); concomitant treatment with proton pump inhibitors and/or H2 receptor antagonists is permitted; Other active malignant tumors within 3.5 years; 4. Any of the following: (1) Pregnant women; (2) Lactating women; (3) Fertility and unwilling to use appropriate contraceptive measures; (4) Received probiotic treatment within 3 weeks before registration. 5. Do not agree to sign the informed consent; 6. Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons; 7. At the same time receiving experimental treatment of other clinical studies (in the treatment period of clinical study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diarrhea;Intestinal function;Flora changes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient mental state;Treatment compliance; | — |
Countries
China
Contacts
Public ContactLi Haiyan
The Sixth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed