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

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ClinicalTrials.gov Identifier: NCT06039644
Recruitment Status : Recruiting
First Posted : September 15, 2023
Last Update Posted : April 12, 2024
Sponsor:
Collaborator:
Mackay Memorial Hospital
Information provided by (Responsible Party):
GenMont Biotech Incorporation

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: Probiotic Other: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment, Randomized Controlled Trial
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: To Evaluate the Efficacy of Probiotics in Improvement and Prevention of Chemotherapy Associated Side Effectes in Patients With the Breast Cancer
Actual Study Start Date : April 8, 2024
Estimated Primary Completion Date : April 1, 2026
Estimated Study Completion Date : April 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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 Name: Test group
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 Name: Control group


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06039644


Contacts
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Contact: Fang-Kuei Lin, Master +886-6-505-2151 ext 326 meitung@genmont.com.tw
Contact: Wan-Hua Tsai, PhD +886-6-505-2151 ext 322 twh@genmont.com.tw

Locations
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Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Po-Sheng Yang, MD, PhD         
Sponsors and Collaborators
GenMont Biotech Incorporation
Mackay Memorial Hospital
Investigators
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Principal Investigator: Po-Sheng Yang, MD, PhD Mackay Memorial Hospital
More Information
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Responsible Party: GenMont Biotech Incorporation
ClinicalTrials.gov Identifier: NCT06039644    
Other Study ID Numbers: BC2023
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GenMont Biotech Incorporation:
probiotics
chemotherapy side-effects
Breast carcinoma
gut microbiot
 Lactobacillus reuteri
Lactobacillus plantarum
Lactobacillus paracasei
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases