Clinical trial NCT06039644: To Evaluate the Clinical Efficacy of Probiotics in Patients with the Breast Cancer
Official title: To Evaluate the Efficacy of Probiotics in Improvement and Prevention of Chemotherapy Associated Side Effectes in Patients with the Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: probiotics
chemotherapy side-effects
Breast carcinoma
gut microbiot
Lactobacillus reuteri
Lactobacillus plantarum
Lactobacillus paracasei
Lead sponsor: GenMont Biotech Incorporation
Sponsor class: INDUSTRY
Collaborators: name: Mackay Memorial Hospital
First posted: 2023-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment, Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Primary outcomes:
measure: Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks
timeFrame: 24 weeks
measure: Variability in BMI (Body Mass Index)
timeFrame: 24 weeks
measure: Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks
timeFrame: 24 weeks
measure: Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks
timeFrame: 24 weeks
measure: Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks
timeFrame: 24 weeks
measure: Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 24 weeks
timeFrame: 24 weeks
measure: Change from baseline in gut microbiome at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline in gut microbiome at 24 weeks
timeFrame: 24 weeks
measure: Variability in levels of ALT (Alanine Aminotransferase) in IU/L
timeFrame: 24 weeks
measure: Variability in levels of AST (Aspartate Aminotransferase) in IU/L
timeFrame: 24 weeks
measure: Variability in levels of Creatinine in mg/dL
timeFrame: 24 weeks
measure: Variability in levels of Hb (Hemoglobin) in g/dL
timeFrame: 24 weeks
measure: Variability in levels of RBC (Red Blood Cell count) in 10^6/μL
timeFrame: 24 weeks
measure: Variability in levels of Ht (Hematocrite) in %
timeFrame: 24 weeks
measure: Variability in levels of WBC(White Blood Cell count) in 10^3/μL
timeFrame: 24 weeks
measure: Variability in levels of MCV (Mean Corpuscular Volume) in fL
timeFrame: 24 weeks
measure: Variability in levels of MCH (Mean Corpuscular Haemoglobin) in Pg
timeFrame: 24 weeks
measure: Variability in levels of MCHC (Mean Corpuscular Haemoglobin Concentration) in g/dL
timeFrame: 24 weeks
measure: Variability in levels of ANC (Absolute Neutrophil Count) in mm^3
timeFrame: 24 weeks
measure: Variability in levels of platelet in 10^3/μL
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Po-Sheng Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: