To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06039644 |
Recruitment Status :
Recruiting
First Posted : September 15, 2023
Last Update Posted : April 12, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Dietary Supplement: Probiotic Other: Placebo | Not Applicable |
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 |
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 |
- 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.
- 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.
- 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)
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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).
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
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 |
Taiwan | |
Mackay Memorial Hospital | Recruiting |
Taipei, Taiwan | |
Contact: Po-Sheng Yang, MD, PhD |
Principal Investigator: | Po-Sheng Yang, MD, PhD | Mackay Memorial Hospital |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
probiotics chemotherapy side-effects Breast carcinoma gut microbiot |
Lactobacillus reuteri Lactobacillus plantarum Lactobacillus paracasei |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |