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| Name | Class |
|---|---|
| Mackay Memorial Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | Subjects received two probiotic sachets per day |
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| Placebo group | Placebo Comparator | Subjects received two placebo sachets per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks | The FACT-G questionnaire will record the quality of life by subjects at 12-weeks and-24 weeks. There are 4 domains of quality of life will be measured, including physical well-being, social/family well-being, emotional well-being, functional well-being. All domains will sum as total score of 108, and each domain will also evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang-Kuei Lin, Master | Contact | +886-6-505-2151 | 326 | meitung@genmont.com.tw |
| Wan-Hua Tsai, PhD | Contact | +886-6-505-2151 | 322 | twh@genmont.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Po-Sheng Yang, MD, PhD | Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackay Memorial Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Parallel Assignment, Randomized Controlled Trial
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| Placebo | Other | Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin. |
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| 24 weeks |
| Variability in BMI (Body Mass Index) | BMI will calculated with weight and height combined in kg/m^2. Measured every visit (week 0. 3. 6. 9. 12. 15. 18. 21. 24) | 24 weeks |
| Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks | Blood samples will collected to examine the variation of hs-CRP from baseline at 12 weeks. | 12 weeks |
| Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks | Blood samples will collected to examine the variation of hs-CRP from baseline at 24 weeks. | 24 weeks |
| Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks | Blood samples will collected to examine the variation of IL-6 from baseline at 12 weeks. | 12 weeks |
| Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks | Blood samples will collected to examine the variation of IL-6 from baseline at 24 weeks. | 24 weeks |
| Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks | Blood samples will collected to examine the variation of IL-10 from baseline at 12 weeks. | 12 weeks |
| Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks | Blood samples will collected to examine the variation of IL-10 from baseline at 24 weeks. | 24 weeks |
| Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 12 weeks | Blood samples will collected to examine the variation of TNF-α from baseline at 12 weeks. | 12 weeks |
| Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 24 weeks | Blood samples will collected to examine the variation of TNF-α from baseline at 24 weeks. | 24 weeks |
| Change from baseline in gut microbiome at 12 weeks | Fecal sample will collected to extract DNA from the intestinal microbiota to examine the variations of gut microbiome from baseline at 12 weeks by NGS (Next Generation Sequencing) analysis. | 12 weeks |
| Change from baseline in gut microbiome at 24 weeks | Fecal sample will collected to extract DNA from the intestinal microbiota to examine the variations of gut microbiome from baseline at 24 weeks by NGS (Next Generation Sequencing) analysis. | 24 weeks |
| Variability in levels of ALT (Alanine Aminotransferase) in IU/L | ALT levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) | 24 weeks |
| Variability in levels of AST (Aspartate Aminotransferase) in IU/L | AST levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) | 24 weeks |
| Variability in levels of Creatinine in mg/dL | Creatinine levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) | 24 weeks |
| Variability in levels of Hb (Hemoglobin) in g/dL | Hb levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) | 24 weeks |
| Variability in levels of RBC (Red Blood Cell count) in 10^6/μL | RBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) | 24 weeks |
| Variability in levels of Ht (Hematocrite) in % | Ht levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) | 24 weeks |
| Variability in levels of WBC(White Blood Cell count) in 10^3/μL | WBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) | 24 weeks |
| Variability in levels of MCV (Mean Corpuscular Volume) in fL | MCV levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) | 24 weeks |
| Variability in levels of MCH (Mean Corpuscular Haemoglobin) in Pg | MCH levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) | 24 weeks |
| Variability in levels of MCHC (Mean Corpuscular Haemoglobin Concentration) in g/dL | MCHC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) | 24 weeks |
| Variability in levels of ANC (Absolute Neutrophil Count) in mm^3 | Total neutrophils and WBC collected from routine medical records at each visit to calculate ANC levels. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) ANC is calculated as 10 x WBC count in 1000s x (%Segment neutrophils + % bands neutrophils). | 24 weeks |
| Variability in levels of platelet in 10^3/μL | Platelet levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) | 24 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D019602 |
| Food and Beverages |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |