Abemaciclib-Related Diarrhea
Conditions
Interventions
Experimental Group:Huangqin Decoction +Abemaciclib
Placebo Group:Placebo+Abemaciclib
Sponsors
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Female patients aged between 18-75 years; (2) Pathologically diagnosis and histological grading of invasive breast cancer staged as I-III, with pathology results being HR (+), Her-2 (-); (3) Patients undergoing treatment with Abemaciclib; (4) Diarrhea grades ranging from 0 to G=3; (5) ECOG < Grade 3; (6) Voluntarily participating in this trial and having signed a written informed consent form, and being capable of cooperating with long-term follow-up
Exclusion criteria
Exclusion criteria: ? Patients with diarrhea caused by organic diseases (such as inflammatory bowel disease, microscopic colitis, celiac disease, and Crohn's disease); ? Individuals with severe gastrointestinal symptoms such as significant gastrointestinal bleeding; ? Pregnant women or breastfeeding mothers; ? Patients with serious cardiovascular, hematopoietic system diseases, or severe liver and kidney dysfunction; ? Individuals with serious mental illnesses or those incapable of providing informed consent; ? Those who have received diarrhea-related treatment within the past month; ? Participants who have previously taken part in similar clinical studies. ? Other circumstances deemed inappropriate for inclusion in the study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graded Incidence Rate of Diarrhea;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diarrhea Clinical Symptom Score;Frequency and Duration of Diarrhea;Fecal Microbiota Analysis;KPS; | — |
Countries
China
Contacts
Public ContactWu Chunyu
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed