Breast Cancer, Chemotherapy-induced Diarrhea
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSynbiotic 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.
DIETARY_SUPPLEMENTPlacebo 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.
Sponsors
Leeuwenhoek Laboratories Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Absolute Neutrophil Count (ANC) ≥ 1,500/μL without G-CSF support within 14 days of enrollment. 2. Platelet count ≥ 100,000/μL. 3. Hemoglobin ≥ 8.0 g/dL (red blood cell transfusion is permitted prior to enrollment). F. Adequate hepatic function, as defined by: 1. Serum alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal. 2. 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: 1. Severe renal impairment (e.g., estimated creatinine clearance \< 30 mL/min). 2. Interstitial lung disease. 3. Severe dyspnea at rest or the requirement for oxygen therapy. 4. History of major gastrointestinal surgeries, such as gastrectomy or small bowel resection. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade 2 or Higher Diarrhea | During the first 2 months of the intervention. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abemaciclib Dose Intensity | 4 months | To compare the total administered dose of Abemaciclib between the synbiotic and placebo groups. |
| Loperamide Utilization Rate | 4 months | The total amount/dosage of standard anti-diarrhea medication (Loperamide) used by participants to manage GI symptoms. |
| Total Duration of Diarrhea | 4 months | The duration of diarrhea (any grade) experienced by participants during the 4-month study period. |
| Duration of Grade 2 Diarrhea | 4 months | The duration of Grade 2 diarrhea experienced by participants. |
| Changes in Specific Gut Microbiome-Derived Blood Metabolites | Baseline, 2 months, and 4 months. | Evaluation of blood concentration changes in: 1. Short-Chain Fatty Acids (SCFAs): Acetic, Propionic, Butyric, Isobutyric, Valeric, and Isovaleric acids. 2. Tryptophan Pathway: Tryptophan, Serotonin, Indole-acetic acid, Indole propionic acid, and Indole-lactic acid. 3. Bile Acids: Cholic, Chenodeoxycholic, Deoxycholic, and Lithocholic acids. 4. Uremic and Cardiovascular Toxins: Trimethylamine-N-oxide (TMAO), Indoxyl sulfate, p-cresyl sulfate, and Phenylacetylglutamine. |
Countries
Taiwan
Contacts
CONTACTChiao-Wei Lin
Outcome results
None listed