To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic, Placebo.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
To Evaluate the Efficacy of Probiotics in Improvement and Prevention of Chemotherapy Associated Side Effectes in Patients With the Breast Cancer
Overview
Chemotherapy-associated side-effects would affect therapeutic effect, quality of life, and cause permanent harm to breast cancer patients. This study is designed to explore after consumption of probiotics of lactobacillus composite strain powder sachets for 6 months in breast cancer chemotherapy, and whether the improvement of meliorate the side effects, further assists patients completing the chemotherapy.
Detailed description
In 2020, the incidence rate of women's breast cancer in Taiwan was up to 82.1% . The death rate increased to 16%; in 2021, the ranking rose to no.3, and the death rate grew up to 24.6%. In the decades, breast cancer gradually becomes the dominant malignant women's cancer in Taiwan. Besides the lumpectomy, chemotherapy is one of the dominant and important treatments for breast cancer. Beyond the effects of chemotherapy, several side effects rise up. The most common chemotherapy are anthracyclin drugs (doxorubicin and epirubicin) and taxane (docetaxel and paclitaxel ). There are common side effects including neutropenia, hair loss, vomiting, diarrhea, stomatitis, mucositis, peripheral neuropathy, dermatitis, nephrotoxicity, and hepatotoxicity. Currently, most treatments for chemotherapy-induced side effects are symptomatic treatment, but there is no good solution to prevent it.
Interventions
- Dietary supplement Probiotic
Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive). - Other Placebo
Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.
Primary outcome measures
- Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks [Time frame: 24 weeks]
Secondary outcome measures (12)
- Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks [Time frame: 24 weeks]
- Variability in BMI (Body Mass Index) [Time frame: 24 weeks]
- Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks [Time frame: 12 weeks]
- Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks [Time frame: 24 weeks]
- Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks [Time frame: 12 weeks]
- Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks [Time frame: 24 weeks]
- Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks [Time frame: 12 weeks]
- Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks [Time frame: 24 weeks]
- Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 12 weeks [Time frame: 12 weeks]
- Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 24 weeks [Time frame: 24 weeks]
- Change from baseline in gut microbiome at 12 weeks [Time frame: 12 weeks]
- Change from baseline in gut microbiome at 24 weeks [Time frame: 24 weeks]
Eligibility criteria
Inclusion criteria
- Stage I-III breast patients using anthracycline-based and taxane-based chemotherapy (not limited before or after chemotherapy/surgery)
- BMI > 18 kg/m\^2
- Age between 20 and 80 years old
- Patients judged by physicians to participate in this trial and who are willing
Exclusion criteria
- Pregnant or lactating female patients
- Patients with bariatric surgery, gastrointestinal resections, Crohn's disease, celiac disease
- BMI < 18 kg/m\^2
- Patient who have severe allergy to soybeans or peanuts
- Those who are under 20 years old or over 80 years old
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Taiwan · 1 center
- Mackay Memorial Hospital — Taipei
Identifiers
NCT: NCT06039644 · BC2023