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NCT Number: NCT06039644

To Evaluate the Clinical Efficacy of Probiotics 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mackay Memorial Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Po-Sheng Yang, MD, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

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

Placebo

Other

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

Other names: Control group

Primary outcomes

  1. Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks

    Time frame: 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.

Secondary outcomes

  1. Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks

    Time frame: 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.

  2. Variability in BMI (Body Mass Index)

    Time frame: 24 weeks

    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)

  3. Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks

    Time frame: 12 weeks

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

  4. Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks

    Time frame: 24 weeks

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

  5. Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks

    Time frame: 12 weeks

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

  6. Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks

    Time frame: 24 weeks

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

  7. Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks

    Time frame: 12 weeks

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

  8. Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks

    Time frame: 24 weeks

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

  9. Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 12 weeks

    Time frame: 12 weeks

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

  10. Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 24 weeks

    Time frame: 24 weeks

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

  11. Change from baseline in gut microbiome at 12 weeks

    Time frame: 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. Change from baseline in gut microbiome at 24 weeks

    Time frame: 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.

  13. Variability in levels of ALT (Alanine Aminotransferase) in IU/L

    Time frame: 24 weeks

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

  14. Variability in levels of AST (Aspartate Aminotransferase) in IU/L

    Time frame: 24 weeks

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

  15. Variability in levels of Creatinine in mg/dL

    Time frame: 24 weeks

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

  16. Variability in levels of Hb (Hemoglobin) in g/dL

    Time frame: 24 weeks

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

  17. Variability in levels of RBC (Red Blood Cell count) in 10^6/μL

    Time frame: 24 weeks

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

  18. Variability in levels of Ht (Hematocrite) in %

    Time frame: 24 weeks

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

  19. Variability in levels of WBC(White Blood Cell count) in 10^3/μL

    Time frame: 24 weeks

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

  20. Variability in levels of MCV (Mean Corpuscular Volume) in fL

    Time frame: 24 weeks

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

  21. Variability in levels of MCH (Mean Corpuscular Haemoglobin) in Pg

    Time frame: 24 weeks

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

  22. Variability in levels of MCHC (Mean Corpuscular Haemoglobin Concentration) in g/dL

    Time frame: 24 weeks

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

  23. Variability in levels of ANC (Absolute Neutrophil Count) in mm^3

    Time frame: 24 weeks

    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. Variability in levels of platelet in 10^3/μL

    Time frame: 24 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fang-Kuei Lin, Master

CONTACT

[email protected]

+886-6-505-2151 ext. 326

Wan-Hua Tsai, PhD

CONTACT

[email protected]

+886-6-505-2151 ext. 322

Sponsors and collaborators

Lead sponsor

GenMont Biotech Incorporation

Industry

Collaborators

  • Mackay Memorial Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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