乳がん患者におけるプロバイオティクスの臨床効果を評価するには
乳がん患者における化学療法に伴う副作用の改善と予防におけるプロバイオティクスの有効性を評価する
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Taipei、台湾
- Mackay Memorial Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
- Use of antibiotics within 1 month prior to trial initiation
- Long-term, stable use of probiotic or prebiotic supplements within 1 month prior to trial initiation (excluding yogurt and dairy products)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Probiotic group
Subjects received two probiotic sachets per day |
Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive).
他の名前：
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プラセボコンパレーター：Placebo group
Subjects received two placebo sachets per day |
Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks
時間枠：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 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks
時間枠：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. |
24 weeks
|
|
Variability in BMI (Body Mass Index)
時間枠：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) |
24 weeks
|
|
Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks
時間枠：12 weeks
|
Blood samples will collected to examine the variation of hs-CRP from baseline at 12 weeks. |
12 weeks
|
|
Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks
時間枠：24 weeks
|
Blood samples will collected to examine the variation of hs-CRP from baseline at 24 weeks. |
24 weeks
|
|
Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks
時間枠：12 weeks
|
Blood samples will collected to examine the variation of IL-6 from baseline at 12 weeks. |
12 weeks
|
|
Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks
時間枠：24 weeks
|
Blood samples will collected to examine the variation of IL-6 from baseline at 24 weeks. |
24 weeks
|
|
Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks
時間枠：12 weeks
|
Blood samples will collected to examine the variation of IL-10 from baseline at 12 weeks. |
12 weeks
|
|
Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks
時間枠：24 weeks
|
Blood samples will collected to examine the variation of IL-10 from baseline at 24 weeks. |
24 weeks
|
|
Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 12 weeks
時間枠：12 weeks
|
Blood samples will collected to examine the variation of TNF-α from baseline at 12 weeks. |
12 weeks
|
|
Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 24 weeks
時間枠：24 weeks
|
Blood samples will collected to examine the variation of TNF-α from baseline at 24 weeks. |
24 weeks
|
|
Change from baseline in gut microbiome at 12 weeks
時間枠：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 weeks
|
|
Change from baseline in gut microbiome at 24 weeks
時間枠：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. |
24 weeks
|
|
Variability in levels of ALT (Alanine Aminotransferase) in IU/L
時間枠：24 weeks
|
ALT levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks
|
|
Variability in levels of AST (Aspartate Aminotransferase) in IU/L
時間枠：24 weeks
|
AST levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks
|
|
Variability in levels of Creatinine in mg/dL
時間枠：24 weeks
|
Creatinine levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks
|
|
Variability in levels of Hb (Hemoglobin) in g/dL
時間枠：24 weeks
|
Hb levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks
|
|
Variability in levels of RBC (Red Blood Cell count) in 10^6/μL
時間枠：24 weeks
|
RBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks
|
|
Variability in levels of Ht (Hematocrite) in %
時間枠：24 weeks
|
Ht levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks
|
|
Variability in levels of WBC(White Blood Cell count) in 10^3/μL
時間枠：24 weeks
|
WBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks
|
|
Variability in levels of MCV (Mean Corpuscular Volume) in fL
時間枠：24 weeks
|
MCV levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks
|
|
Variability in levels of MCH (Mean Corpuscular Haemoglobin) in Pg
時間枠：24 weeks
|
MCH levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks
|
|
Variability in levels of MCHC (Mean Corpuscular Haemoglobin Concentration) in g/dL
時間枠：24 weeks
|
MCHC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks
|
|
Variability in levels of ANC (Absolute Neutrophil Count) in mm^3
時間枠：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 weeks
|
|
Variability in levels of platelet in 10^3/μL
時間枠：24 weeks
|
Platelet levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks
|
協力者と研究者
捜査官
- 主任研究者：Po-Sheng Yang, MD, PhD、Mackay Memorial Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BC2023
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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