- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07605728
Probiotics for Abemaciclib-Induced Abdominal Discomfort.
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chiao-Wei Lin
- Número de teléfono: 202 +886-2-2377-2318
- Correo electrónico: cwlin@lwhklab.com.tw
Ubicaciones de estudio
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Taipei, Taiwán
- Reclutamiento
- National Taiwan University Hospital
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Contacto:
- Wei-Li Ma
- Número de teléfono: 263155 +886-2-2312-3456
- Correo electrónico: excellent0667@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Synbiotic Supplement followed by Placebo
Participants in this sequence will receive the synbiotic supplement for the first 2 months, followed by a 2-month period of receiving the placebo.
All participants continue their prescribed Abemaciclib therapy.
Standard anti-diarrhea medication (Loperamide) is available as needed.
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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.
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Comparador de placebos: Placebo followed by Synbiotic Supplement
Participants in this sequence will receive the placebo for the first 2 months, followed by a 2-month period of receiving the synbiotic supplement.
All participants continue their prescribed Abemaciclib therapy.
Standard anti-diarrhea medication (Loperamide) is available as needed.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of Grade 2 or Higher Diarrhea
Periodo de tiempo: During the first 2 months of the intervention.
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The primary endpoint is the proportion of patients experiencing Grade 2 or higher diarrhea, defined as an increase of 4 to 6 stools per day from baseline.
This measure will compare the incidence between the experimental and control groups across each treatment cycle during the first two months.
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During the first 2 months of the intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Abemaciclib Dose Intensity
Periodo de tiempo: 4 months
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To compare the total administered dose of Abemaciclib between the synbiotic and placebo groups.
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4 months
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Loperamide Utilization Rate
Periodo de tiempo: 4 months
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The total amount/dosage of standard anti-diarrhea medication (Loperamide) used by participants to manage GI symptoms.
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4 months
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Total Duration of Diarrhea
Periodo de tiempo: 4 months
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The duration of diarrhea (any grade) experienced by participants during the 4-month study period.
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4 months
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Duration of Grade 2 Diarrhea
Periodo de tiempo: 4 months
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The duration of Grade 2 diarrhea experienced by participants.
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4 months
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Changes in Specific Gut Microbiome-Derived Blood Metabolites
Periodo de tiempo: Baseline, 2 months, and 4 months.
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Evaluation of blood concentration changes in:
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Baseline, 2 months, and 4 months.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LL-IRB-2501
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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