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

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
GenMont Biotech Incorporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring probiotics, chemotherapy side-effects, Breast carcinoma, gut microbiot, Lactobacillus reuteri, Lactobacillus plantarum, Lactobacillus paracasei

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Probiotic group

    Placebo group

    Arm Description

    Subjects received two probiotic sachets per day

    Subjects received two placebo sachets per day

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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)
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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).
    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)

    Full Information

    First Posted
    September 6, 2023
    Last Updated
    October 12, 2023
    Sponsor
    GenMont Biotech Incorporation
    Collaborators
    Mackay Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06039644
    Brief Title
    To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer
    Official Title
    To Evaluate the Efficacy of Probiotics in Improvement and Prevention of Chemotherapy Associated Side Effectes in Patients With the Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2025 (Anticipated)
    Study Completion Date
    December 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GenMont Biotech Incorporation
    Collaborators
    Mackay Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    probiotics, chemotherapy side-effects, Breast carcinoma, gut microbiot, Lactobacillus reuteri, Lactobacillus plantarum, Lactobacillus paracasei

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel Assignment, Randomized Controlled Trial
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic group
    Arm Type
    Experimental
    Arm Description
    Subjects received two probiotic sachets per day
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects received two placebo sachets per day
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Probiotic
    Other Intervention Name(s)
    Test group
    Intervention Description
    Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive).
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Control group
    Intervention Description
    Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.
    Primary Outcome Measure Information:
    Title
    Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks
    Description
    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.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks
    Description
    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.
    Time Frame
    24 weeks
    Title
    Variability in BMI (Body Mass Index)
    Description
    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)
    Time Frame
    24 weeks
    Title
    Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks
    Description
    Blood samples will collected to examine the variation of hs-CRP from baseline at 12 weeks.
    Time Frame
    12 weeks
    Title
    Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks
    Description
    Blood samples will collected to examine the variation of hs-CRP from baseline at 24 weeks.
    Time Frame
    24 weeks
    Title
    Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks
    Description
    Blood samples will collected to examine the variation of IL-6 from baseline at 12 weeks.
    Time Frame
    12 weeks
    Title
    Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks
    Description
    Blood samples will collected to examine the variation of IL-6 from baseline at 24 weeks.
    Time Frame
    24 weeks
    Title
    Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks
    Description
    Blood samples will collected to examine the variation of IL-10 from baseline at 12 weeks.
    Time Frame
    12 weeks
    Title
    Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks
    Description
    Blood samples will collected to examine the variation of IL-10 from baseline at 24 weeks.
    Time Frame
    24 weeks
    Title
    Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 12 weeks
    Description
    Blood samples will collected to examine the variation of TNF-α from baseline at 12 weeks.
    Time Frame
    12 weeks
    Title
    Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 24 weeks
    Description
    Blood samples will collected to examine the variation of TNF-α from baseline at 24 weeks.
    Time Frame
    24 weeks
    Title
    Change from baseline in gut microbiome at 12 weeks
    Description
    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.
    Time Frame
    12 weeks
    Title
    Change from baseline in gut microbiome at 24 weeks
    Description
    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.
    Time Frame
    24 weeks
    Title
    Variability in levels of ALT (Alanine Aminotransferase) in IU/L
    Description
    ALT levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
    Time Frame
    24 weeks
    Title
    Variability in levels of AST (Aspartate Aminotransferase) in IU/L
    Description
    AST levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
    Time Frame
    24 weeks
    Title
    Variability in levels of Creatinine in mg/dL
    Description
    Creatinine levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
    Time Frame
    24 weeks
    Title
    Variability in levels of Hb (Hemoglobin) in g/dL
    Description
    Hb levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
    Time Frame
    24 weeks
    Title
    Variability in levels of RBC (Red Blood Cell count) in 10^6/μL
    Description
    RBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
    Time Frame
    24 weeks
    Title
    Variability in levels of Ht (Hematocrite) in %
    Description
    Ht levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
    Time Frame
    24 weeks
    Title
    Variability in levels of WBC(White Blood Cell count) in 10^3/μL
    Description
    WBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
    Time Frame
    24 weeks
    Title
    Variability in levels of MCV (Mean Corpuscular Volume) in fL
    Description
    MCV levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
    Time Frame
    24 weeks
    Title
    Variability in levels of MCH (Mean Corpuscular Haemoglobin) in Pg
    Description
    MCH levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
    Time Frame
    24 weeks
    Title
    Variability in levels of MCHC (Mean Corpuscular Haemoglobin Concentration) in g/dL
    Description
    MCHC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
    Time Frame
    24 weeks
    Title
    Variability in levels of ANC (Absolute Neutrophil Count) in mm^3
    Description
    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).
    Time Frame
    24 weeks
    Title
    Variability in levels of platelet in 10^3/μL
    Description
    Platelet levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fang-Kuei Lin, Master
    Phone
    +886-6-505-2151
    Ext
    326
    Email
    meitung@genmont.com.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wan-Hua Tsai, PhD
    Phone
    +886-6-505-2151
    Ext
    322
    Email
    twh@genmont.com.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Po-Sheng Yang, MD, PhD
    Organizational Affiliation
    Mackay Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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