Probiotics for Abemaciclib-Induced Abdominal Discomfort.

Официальное название

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.

Обзор

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.

Подробное описание

This study investigates whether a specific "Synbiotic" supplement (containing probiotics, prebiotics, and postbiotics) can help reduce abdominal discomfort, particularly diarrhea, in breast cancer patients taking the targeted therapy drug, Abemaciclib. Abemaciclib is highly effective in preventing breast cancer recurrence but frequently causes gastrointestinal side effects. While standard anti-diarrhea medications (Loperamide) are used, many patients still experience discomfort. Preliminary observations suggest that certain probiotics and polyphenols may help restore intestinal balance and reduce these symptoms. Participants will be randomly assigned to two groups. During the 4-month study period, everyone will receive both the synbiotic supplement and a placebo at different stages (a crossover design). All participants will continue their standard cancer treatment and have access to standard anti-diarrhea medication as needed. The study will also analyze blood samples to see if the supplement improves metabolic health.

Вмешательства

• Пищевая добавка Synbiotic supplement followed by Placebo
  The synbiotic supplement contains Bifidobacterium longum (probiotics), Oligonol® lychee polyphenol (prebiotics), and functional postbiotics. Participants will take two capsules daily for 2 months during the assigned study phase. This intervention is administered orally to evaluate its efficacy in alleviating Abemaciclib-induced abdominal discomfort.
• Пищевая добавка Placebo followed by Probiotics
  Participants in this sequence will receive the placebo for the first 2 months, followed by a 2-month period of receiving the synbiotic supplement (containing Bifidobacterium longum, lychee polyphenol, and postbiotics). All participants continue their prescribed Abemaciclib and endocrine therapy. Standard anti-diarrhea medication (Loperamide) is available as needed.

Первичные конечные точки

• Incidence of Grade 2 or Higher Diarrhea [Срок оценки: During the first 2 months of the intervention.]

Вторичные конечные точки (5)

• Abemaciclib Dose Intensity [Срок оценки: 4 months]
• Loperamide Utilization Rate [Срок оценки: 4 months]
• Total Duration of Diarrhea [Срок оценки: 4 months]
• Duration of Grade 2 Diarrhea [Срок оценки: 4 months]
• Changes in Specific Gut Microbiome-Derived Blood Metabolites [Срок оценки: Baseline, 2 months, and 4 months.]

Критерии участия

Критерии включения

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.

Критерии исключения

A. Currently pregnant or breastfeeding. B. Received systemic antibiotic therapy for active viral, bacterial, or fungal infections within 2 weeks before the first dose of the study intervention.

C. Severe pre-existing medical conditions that, in the investigator's judgment, preclude participation, including but not limited to the following:

• Severe renal impairment (e.g., estimated creatinine clearance < 30 mL/min).
• Interstitial lung disease.
• Severe dyspnea at rest or the requirement for oxygen therapy.
• History of major gastrointestinal surgeries, such as gastrectomy or small bowel resection.
• Pre-existing Crohn's disease, ulcerative colitis, or other chronic conditions that cause clinically significant diarrhea.

D. History of the following cardiovascular conditions: syncope of cardiovascular origin, ventricular arrhythmias of pathological origin (including ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: Patients with atrial fibrillation that is controlled and stable for at least 30 days before randomization are eligible.

E. Unwillingness or inability to provide written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT07605728 · LL-IRB-2501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗