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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
80
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.
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.
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGIncidence of Grade 2 or Higher Diarrhea
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.
Time frame: During the first 2 months of the intervention.
Abemaciclib Dose Intensity
To compare the total administered dose of Abemaciclib between the synbiotic and placebo groups.
Time frame: 4 months
Loperamide Utilization Rate
The total amount/dosage of standard anti-diarrhea medication (Loperamide) used by participants to manage GI symptoms.
Time frame: 4 months
Total Duration of Diarrhea
The duration of diarrhea (any grade) experienced by participants during the 4-month study period.
Time frame: 4 months
Duration of Grade 2 Diarrhea
The duration of Grade 2 diarrhea experienced by participants.
Time frame: 4 months
Changes in Specific Gut Microbiome-Derived Blood Metabolites
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.
Time frame: Baseline, 2 months, and 4 months.
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