PDF(Pubmed)
Abstract：
BACKGROUND: In recent years, advancements in cancer treatment have enabled cancer cell inhibition, leading to improved patient outcomes. However, the side effects of chemotherapy, especially leukopenia, impact patients\' ability to tolerate their treatments and affect their quality of life. Traditional Chinese medicine is thought to provide complementary cancer treatment to improve the quality of life and prolong survival time among patients with cancer.
OBJECTIVE: This study aims to evaluate the effectiveness of Chinese herbal medicine (CHM) as a complementary treatment for neutropenia prevention and immunity modulation during chemotherapy in patients with breast cancer.
METHODS: We will conduct a real-world pragmatic clinical trial to evaluate the effectiveness of CHM as a supplementary therapy to prevent neutropenia in patients with breast cancer undergoing chemotherapy. Patients will be classified into CHM or non-CHM groups based on whether they received CHM during chemotherapy. Using generalized estimating equations or repeated measures ANOVA, we will assess differences in white blood cell counts, absolute neutrophil counts, immune cells, and programmed cell death protein 1 (PD-1) expression levels between the 2 groups.
RESULTS: This study was approved by the research ethics committee of Hualien Tzu Chi Hospital (IRB 110-168-A). The enrollment process began in September 2021 and will stop in December 2024. A total of 140 patients will be recruited. Data cleaning and analysis are expected to finish in the middle of 2025.
CONCLUSIONS: Traditional Chinese medicine is the most commonly used complementary medicine, and it has been reported to significantly alleviate chemotherapy-related side effects. This study\'s findings may contribute to developing effective interventions targeting chemotherapy-related neutropenia among patients with breast cancer in clinical practice.
BACKGROUND: International Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes.
UNASSIGNED: DERR1-10.2196/55662.
OBJECTIVE: This study aims to evaluate the effectiveness of Chinese herbal medicine (CHM) as a complementary treatment for neutropenia prevention and immunity modulation during chemotherapy in patients with breast cancer.
METHODS: We will conduct a real-world pragmatic clinical trial to evaluate the effectiveness of CHM as a supplementary therapy to prevent neutropenia in patients with breast cancer undergoing chemotherapy. Patients will be classified into CHM or non-CHM groups based on whether they received CHM during chemotherapy. Using generalized estimating equations or repeated measures ANOVA, we will assess differences in white blood cell counts, absolute neutrophil counts, immune cells, and programmed cell death protein 1 (PD-1) expression levels between the 2 groups.
RESULTS: This study was approved by the research ethics committee of Hualien Tzu Chi Hospital (IRB 110-168-A). The enrollment process began in September 2021 and will stop in December 2024. A total of 140 patients will be recruited. Data cleaning and analysis are expected to finish in the middle of 2025.
CONCLUSIONS: Traditional Chinese medicine is the most commonly used complementary medicine, and it has been reported to significantly alleviate chemotherapy-related side effects. This study\'s findings may contribute to developing effective interventions targeting chemotherapy-related neutropenia among patients with breast cancer in clinical practice.
BACKGROUND: International Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes.
UNASSIGNED: DERR1-10.2196/55662.
摘要：
背景：近年来，癌症治疗的进步使癌细胞得到抑制，改善患者预后。然而,化疗的副作用，尤其是白细胞减少症,影响患者耐受治疗的能力，影响他们的生活质量。中医被认为可以提供补充癌症治疗，以改善癌症患者的生活质量并延长生存时间。
目的：本研究旨在评估中药（CHM）作为乳腺癌患者化疗期间中性粒细胞减少症预防和免疫调节的补充治疗的有效性。
方法：我们将进行一项现实世界的务实临床试验，以评估CHM作为补充疗法预防接受化疗的乳腺癌患者中性粒细胞减少症的有效性。根据患者在化疗期间是否接受CHM，将患者分为CHM或非CHM组。使用广义估计方程或重复测量方差分析，我们将评估白细胞计数的差异，中性粒细胞绝对计数,免疫细胞，程序性细胞死亡蛋白1(PD-1)表达水平在2组间比较。
结果：本研究获得花莲慈济医院研究伦理委员会（IRB110-168-A）批准。注册过程于2021年9月开始，并将于2024年12月停止。总共将招募140名患者。数据清理和分析预计将在2025年中期完成。
结论:中药是最常用的补充药物,据报道，它可以显著减轻化疗相关的副作用。这项研究的发现可能有助于在临床实践中开发针对乳腺癌患者化疗相关中性粒细胞减少症的有效干预措施。
背景：国际传统医学临床试验注册ITMCTR2023000054;https://tinyurl.com/yc353hes。
■DERR1-10.2196/55662。
目的：本研究旨在评估中药（CHM）作为乳腺癌患者化疗期间中性粒细胞减少症预防和免疫调节的补充治疗的有效性。
方法：我们将进行一项现实世界的务实临床试验，以评估CHM作为补充疗法预防接受化疗的乳腺癌患者中性粒细胞减少症的有效性。根据患者在化疗期间是否接受CHM，将患者分为CHM或非CHM组。使用广义估计方程或重复测量方差分析，我们将评估白细胞计数的差异，中性粒细胞绝对计数,免疫细胞，程序性细胞死亡蛋白1(PD-1)表达水平在2组间比较。
结果：本研究获得花莲慈济医院研究伦理委员会（IRB110-168-A）批准。注册过程于2021年9月开始，并将于2024年12月停止。总共将招募140名患者。数据清理和分析预计将在2025年中期完成。
结论:中药是最常用的补充药物,据报道，它可以显著减轻化疗相关的副作用。这项研究的发现可能有助于在临床实践中开发针对乳腺癌患者化疗相关中性粒细胞减少症的有效干预措施。
背景：国际传统医学临床试验注册ITMCTR2023000054;https://tinyurl.com/yc353hes。
■DERR1-10.2196/55662。
