Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Carcinoma

Breast Diseases

Skin Diseases

Other Dietary Supplements

All Drugs and Chemicals

Acidophilus

Subjects received two probiotic sachets per day

Subjects received two placebo sachets per day

Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive).

Probiotic

Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.

Placebo

Fang-Kuei Lin, Master

Wan-Hua Tsai, PhD

Po-Sheng Yang, MD, PhD

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.

Parallel Assignment, Randomized Controlled Trial

To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer

To Evaluate the Efficacy of Probiotics in Improvement and Prevention of Chemotherapy Associated Side Effectes in Patients With the Breast Cancer

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.

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.

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)

Blood samples will collected to examine the variation of hs-CRP from baseline at 12 weeks.

Blood samples will collected to examine the variation of hs-CRP from baseline at 24 weeks.

Blood samples will collected to examine the variation of IL-6 from baseline at 12 weeks.

Blood samples will collected to examine the variation of IL-6 from baseline at 24 weeks.

Blood samples will collected to examine the variation of IL-10 from baseline at 12 weeks.

Blood samples will collected to examine the variation of IL-10 from baseline at 24 weeks.

Blood samples will collected to examine the variation of TNF-α from baseline at 12 weeks.

Blood samples will collected to examine the variation of TNF-α from baseline at 24 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.

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.

ALT levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

AST levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

Creatinine levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

Hb levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

RBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

Ht levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

WBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

MCV levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

MCH levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

MCHC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

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).

Platelet levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer	NCT06039644	Breast Cancer	Probiotic Placebo	20 Years - 80 Years	GenMont Biotech Incorporation
To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer	NCT06039644	Breast Cancer	Probiotic Placebo	20 Years - 80 Years	GenMont Biotech Incorporation
To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer	NCT06039644	Breast Cancer	Probiotic Placebo	20 Years - 80 Years	GenMont Biotech Incorporation

Spots Global Cancer Trial Database for lactobacillus paracasei