Breast CancerNCT06039644
To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer
A study testing Probiotic in people with Breast Cancer, run by GenMont Biotech Incorporation at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Mackay Memorial Hospital
Taipei
Po-Sheng Yang, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Probiotic, Placebo
- Keywords
- probiotics, chemotherapy side-effects, Breast carcinoma, gut microbiot, Lactobacillus reuteri, Lactobacillus plantarum, Lactobacillus paracasei
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Test group
Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive).
PlaceboOther
Also called Control group
Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Subjects received two probiotic sachets per day Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Subjects received two placebo sachets per day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (24)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start8 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment, Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GenMont Biotech Incorporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mackay Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Po-Sheng Yang, MD, PhD, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039644
- Sponsor's protocol ID
- BC2023
- Status last verified
- Mar 2026
- First submitted
- 6 Sep 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy of Probiotics in Improvement and Prevention of Chemotherapy Associated Side Effectes in Patients With the Breast Cancer
- ClinicalTrials.gov ID
- NCT06039644
- Acronym / sponsor ID
- BC2023
- Conditions
- Breast Cancer
- Keywords
- probiotics, chemotherapy side-effects, Breast carcinoma, gut microbiot, Lactobacillus reuteri, Lactobacillus plantarum, Lactobacillus paracasei
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GenMont Biotech IncorporationIndustry (pharma, biotech, devices)
- Collaborators
- Mackay Memorial Hospital
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment, Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: ProbioticSubjects received two probiotic sachets per day |
| Placebo group | Placebo comparator | Other: PlaceboSubjects received two placebo sachets per day |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: Test groupThree-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive). | Dietary supplement | Probiotic group |
| PlaceboAlso: Control groupSame additives to Probiotic group but replace probiotics with corn starch and Maltodextrin. | Other | Placebo group |
Primary outcome
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.
24 secondary outcomes
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
Variability in BMI (Body Mass Index)
Time frame: 24 weeks
Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks
Time frame: 12 weeks
Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks
Time frame: 24 weeks
Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks
Time frame: 12 weeks
Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks
Time frame: 24 weeks
Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks
Time frame: 12 weeks
Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks
Time frame: 24 weeks
Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 12 weeks
Time frame: 12 weeks
Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 24 weeks
Time frame: 24 weeks
Change from baseline in gut microbiome at 12 weeks
Time frame: 12 weeks
Change from baseline in gut microbiome at 24 weeks
Time frame: 24 weeks
Variability in levels of ALT (Alanine Aminotransferase) in IU/L
Time frame: 24 weeks
Variability in levels of AST (Aspartate Aminotransferase) in IU/L
Time frame: 24 weeks
Variability in levels of Creatinine in mg/dL
Time frame: 24 weeks
Variability in levels of Hb (Hemoglobin) in g/dL
Time frame: 24 weeks
Variability in levels of RBC (Red Blood Cell count) in 10^6/μL
Time frame: 24 weeks
Variability in levels of Ht (Hematocrite) in %
Time frame: 24 weeks
Variability in levels of WBC(White Blood Cell count) in 10^3/μL
Time frame: 24 weeks
Variability in levels of MCV (Mean Corpuscular Volume) in fL
Time frame: 24 weeks
Variability in levels of MCH (Mean Corpuscular Haemoglobin) in Pg
Time frame: 24 weeks
Variability in levels of MCHC (Mean Corpuscular Haemoglobin Concentration) in g/dL
Time frame: 24 weeks
Variability in levels of ANC (Absolute Neutrophil Count) in mm^3
Time frame: 24 weeks
Variability in levels of platelet in 10^3/μL
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Po-Sheng Yang, MD, PhD principal investigator
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Breast Cancer, run by GenMont Biotech Incorporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang-Kuei Lin, Master (+886-6-505-2151 ext. 326, meitung@genmont.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.