To Evaluate the Efficacy of Probiotics in Improvement and Prevention of Chemotherapy Associated Side Effectes in Patients With the Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Probiotic group
Subjects received two probiotic sachets per day
干预措施: Probiotic (Dietary Supplement)
Placebo group
Subjects received two placebo sachets per day
干预措施: Placebo (Other)
结局指标
主要结局
Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks
时间窗: 24 weeks
The questionnaire will finished to record the side effects, including nausea, vomiting, diarrhea, stomatitis, peripheral neuropathy, skin rashes, and hand-food syndrome before and after the treatment.
次要结局
- Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks(24 weeks)
- Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks(24 weeks)
- Variability in levels of AST (Aspartate Aminotransferase) in IU/L(24 weeks)
- Variability in levels of platelet in 10^3/μL(24 weeks)
- Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks(12 weeks)
- Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 12 weeks(12 weeks)
- Variability in BMI (Body Mass Index)(24 weeks)
- Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks(12 weeks)
- Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks(12 weeks)
- Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks(24 weeks)
- Change from baseline in gut microbiome at 24 weeks(24 weeks)
- Variability in levels of MCV (Mean Corpuscular Volume) in fL(24 weeks)
- Variability in levels of ANC (Absolute Neutrophil Count) in mm^3(24 weeks)
- Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks(24 weeks)
- Variability in levels of ALT (Alanine Aminotransferase) in IU/L(24 weeks)
- Variability in levels of Creatinine in mg/dL(24 weeks)
- Variability in levels of Hb (Hemoglobin) in g/dL(24 weeks)
- Variability in levels of MCH (Mean Corpuscular Haemoglobin) in Pg(24 weeks)
- Variability in levels of MCHC (Mean Corpuscular Haemoglobin Concentration) in g/dL(24 weeks)
- Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 24 weeks(24 weeks)
- Variability in levels of WBC(White Blood Cell count) in 10^3/μL(24 weeks)
- Change from baseline in gut microbiome at 12 weeks(12 weeks)
- Variability in levels of RBC (Red Blood Cell count) in 10^6/μL(24 weeks)
- Variability in levels of Ht (Hematocrite) in %(24 weeks)