A Randomized, Phase II Study About Probiotics to Alleviate Abemaciclib-induced Abdominal Discomfort Under Standard Anti-diarrhea Drug Loperamide and Changes of Metabolic Factors in Blood.
This study aims to evaluate whether the addition of probiotics can help reduce abdominal discomfort (such as diarrhea) in breast cancer patients receiving Abemaciclib treatment. Abemaciclib is an effective targeted therapy but often causes gastrointestinal side effects. While Loperamide is the standard treatment for diarrhea, this study explores if probiotics can provide additional relief and improve metabolic health.Participants will be randomly assigned to receive either probiotics or a placebo alongside their standard care. The study will monitor the frequency of abdominal symptoms and analyze blood samples to observe changes in metabolic factors.
⁃ A. Adults with hormone receptor-positive (HR+) early breast cancer were confirmed.
⁃ B. At least 18 years old at the time of signing the informed consent. C. Candidates for adjuvant endocrine therapy in combination with Abemaciclib (either NHI-reimbursed or self-funded), as determined by the primary treating physician. Prior chemotherapy requirement: Must have completed prior adjuvant chemotherapy at least 21 days before enrollment. All chemotherapy-related toxicities (except alopecia or Grade 2 peripheral neuropathy) must have resolved to ≤ Grade 1.
⁃ D. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
⁃ E. Adequate bone marrow function as defined by:
• Absolute Neutrophil Count (ANC) ≥ 1,500/μL without G-CSF support within 14 days of enrollment.
• Platelet count ≥ 100,000/μL.
• Hemoglobin ≥ 8.0 g/dL (red blood cell transfusion is permitted prior to enrollment).
⁃ F. Adequate hepatic function, as defined by:
• Serum alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal.
• Total bilirubin (T-bil) ≤ 1.5× the upper limit of normal. G. Willingness to refrain from using any other oral probiotics or prebiotics from the first dose of the study intervention (Synbiotic Supplement or placebo) through study completion.
⁃ H. Ability to communicate with study personnel and willingness to comply with study visits, treatment plans, and other trial regulations.