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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Dietary supplement: Probiotic; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang-Kuei Lin, Master; Phone Number: 326 +886-6-505-2151; Email: meitung@genmont.com.tw
• Study Contact Backup: Name: Wan-Hua Tsai, PhD; Phone Number: 322 +886-6-505-2151; Email: twh@genmont.com.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Mackay Memorial Hospital
    • Contact: Po-Sheng Yang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Subjects received two placebo sachets per day	Other: Placebo; Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.; Other Names: Control group
Experimental: Probiotic group; Subjects received two probiotic sachets per day	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 Names: Test group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: GenMont Biotech Incorporation
• Collaborators: Mackay Memorial Hospital
• Investigators: Principal Investigator: Po-Sheng Yang, MD, PhD, Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: probiotics; Lactobacillus plantarum; Lactobacillus reuteri; Breast carcinoma; Lactobacillus paracasei; gut microbiot; chemotherapy side-effects
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Control Groups; Probiotics
• Other Study ID Numbers: BC2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No