Effectiveness of Chinese Herbal Medicine as a Complementary Treatment for Neutropenia Prevention and Immunity Modulation During Chemotherapy in Patients With Breast Cancer: Protocol for a Real-World Pragmatic Clinical Trial

BackgroundIn 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. ObjectiveThis 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. MethodsWe 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. ResultsThis 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. ConclusionsTraditional 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. Trial RegistrationInternational Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes International Registered Report Identifier (IRRID)DERR1-10.2196/55662 Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Kai-Hung Wang [verfasserIn] Hsuan-Shu Shen [verfasserIn] Sung-Chao Chu [verfasserIn] Tso-Fu Wang [verfasserIn] Ching-Wei Lin [verfasserIn] Wei-Han Huang [verfasserIn] Yi-Feng Wu [verfasserIn] Ching-Chun Ho [verfasserIn] Cheng-Yoong Pang [verfasserIn] Chi-Cheng Li [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2024

Übergeordnetes Werk:	In: JMIR Research Protocols - JMIR Publications, 2013, 13, p e55662(2024)
Übergeordnetes Werk:	volume:13, p e55662 ; year:2024

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.2196/55662

Katalog-ID:	DOAJ092275400

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allfields	10.2196/55662 doi (DE-627)DOAJ092275400 (DE-599)DOAJd55703e1f9864336b57a574fed2933de DE-627 ger DE-627 rakwb eng R858-859.7 Kai-Hung Wang verfasserin aut Effectiveness of Chinese Herbal Medicine as a Complementary Treatment for Neutropenia Prevention and Immunity Modulation During Chemotherapy in Patients With Breast Cancer: Protocol for a Real-World Pragmatic Clinical Trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier BackgroundIn 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. ObjectiveThis 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. MethodsWe 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. ResultsThis 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. ConclusionsTraditional 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. Trial RegistrationInternational Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes International Registered Report Identifier (IRRID)DERR1-10.2196/55662 Medicine R Computer applications to medicine. Medical informatics Hsuan-Shu Shen verfasserin aut Sung-Chao Chu verfasserin aut Tso-Fu Wang verfasserin aut Ching-Wei Lin verfasserin aut Wei-Han Huang verfasserin aut Yi-Feng Wu verfasserin aut Ching-Chun Ho verfasserin aut Cheng-Yoong Pang verfasserin aut Chi-Cheng Li verfasserin aut In JMIR Research Protocols JMIR Publications, 2013 13, p e55662(2024) (DE-627)749502304 (DE-600)2719222-2 19290748 nnns volume:13, p e55662 year:2024 https://doi.org/10.2196/55662 kostenfrei https://doaj.org/article/d55703e1f9864336b57a574fed2933de kostenfrei https://www.researchprotocols.org/2024/1/e55662 kostenfrei https://doaj.org/toc/1929-0748 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13, p e55662 2024
spelling	10.2196/55662 doi (DE-627)DOAJ092275400 (DE-599)DOAJd55703e1f9864336b57a574fed2933de DE-627 ger DE-627 rakwb eng R858-859.7 Kai-Hung Wang verfasserin aut Effectiveness of Chinese Herbal Medicine as a Complementary Treatment for Neutropenia Prevention and Immunity Modulation During Chemotherapy in Patients With Breast Cancer: Protocol for a Real-World Pragmatic Clinical Trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier BackgroundIn 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. ObjectiveThis 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. MethodsWe 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. ResultsThis 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. ConclusionsTraditional 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. Trial RegistrationInternational Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes International Registered Report Identifier (IRRID)DERR1-10.2196/55662 Medicine R Computer applications to medicine. Medical informatics Hsuan-Shu Shen verfasserin aut Sung-Chao Chu verfasserin aut Tso-Fu Wang verfasserin aut Ching-Wei Lin verfasserin aut Wei-Han Huang verfasserin aut Yi-Feng Wu verfasserin aut Ching-Chun Ho verfasserin aut Cheng-Yoong Pang verfasserin aut Chi-Cheng Li verfasserin aut In JMIR Research Protocols JMIR Publications, 2013 13, p e55662(2024) (DE-627)749502304 (DE-600)2719222-2 19290748 nnns volume:13, p e55662 year:2024 https://doi.org/10.2196/55662 kostenfrei https://doaj.org/article/d55703e1f9864336b57a574fed2933de kostenfrei https://www.researchprotocols.org/2024/1/e55662 kostenfrei https://doaj.org/toc/1929-0748 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13, p e55662 2024
allfields_unstemmed	10.2196/55662 doi (DE-627)DOAJ092275400 (DE-599)DOAJd55703e1f9864336b57a574fed2933de DE-627 ger DE-627 rakwb eng R858-859.7 Kai-Hung Wang verfasserin aut Effectiveness of Chinese Herbal Medicine as a Complementary Treatment for Neutropenia Prevention and Immunity Modulation During Chemotherapy in Patients With Breast Cancer: Protocol for a Real-World Pragmatic Clinical Trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier BackgroundIn 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. ObjectiveThis 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. MethodsWe 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. ResultsThis 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. ConclusionsTraditional 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. Trial RegistrationInternational Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes International Registered Report Identifier (IRRID)DERR1-10.2196/55662 Medicine R Computer applications to medicine. Medical informatics Hsuan-Shu Shen verfasserin aut Sung-Chao Chu verfasserin aut Tso-Fu Wang verfasserin aut Ching-Wei Lin verfasserin aut Wei-Han Huang verfasserin aut Yi-Feng Wu verfasserin aut Ching-Chun Ho verfasserin aut Cheng-Yoong Pang verfasserin aut Chi-Cheng Li verfasserin aut In JMIR Research Protocols JMIR Publications, 2013 13, p e55662(2024) (DE-627)749502304 (DE-600)2719222-2 19290748 nnns volume:13, p e55662 year:2024 https://doi.org/10.2196/55662 kostenfrei https://doaj.org/article/d55703e1f9864336b57a574fed2933de kostenfrei https://www.researchprotocols.org/2024/1/e55662 kostenfrei https://doaj.org/toc/1929-0748 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13, p e55662 2024
allfieldsGer	10.2196/55662 doi (DE-627)DOAJ092275400 (DE-599)DOAJd55703e1f9864336b57a574fed2933de DE-627 ger DE-627 rakwb eng R858-859.7 Kai-Hung Wang verfasserin aut Effectiveness of Chinese Herbal Medicine as a Complementary Treatment for Neutropenia Prevention and Immunity Modulation During Chemotherapy in Patients With Breast Cancer: Protocol for a Real-World Pragmatic Clinical Trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier BackgroundIn 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. ObjectiveThis 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. MethodsWe 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. ResultsThis 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. ConclusionsTraditional 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. Trial RegistrationInternational Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes International Registered Report Identifier (IRRID)DERR1-10.2196/55662 Medicine R Computer applications to medicine. Medical informatics Hsuan-Shu Shen verfasserin aut Sung-Chao Chu verfasserin aut Tso-Fu Wang verfasserin aut Ching-Wei Lin verfasserin aut Wei-Han Huang verfasserin aut Yi-Feng Wu verfasserin aut Ching-Chun Ho verfasserin aut Cheng-Yoong Pang verfasserin aut Chi-Cheng Li verfasserin aut In JMIR Research Protocols JMIR Publications, 2013 13, p e55662(2024) (DE-627)749502304 (DE-600)2719222-2 19290748 nnns volume:13, p e55662 year:2024 https://doi.org/10.2196/55662 kostenfrei https://doaj.org/article/d55703e1f9864336b57a574fed2933de kostenfrei https://www.researchprotocols.org/2024/1/e55662 kostenfrei https://doaj.org/toc/1929-0748 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13, p e55662 2024
allfieldsSound	10.2196/55662 doi (DE-627)DOAJ092275400 (DE-599)DOAJd55703e1f9864336b57a574fed2933de DE-627 ger DE-627 rakwb eng R858-859.7 Kai-Hung Wang verfasserin aut Effectiveness of Chinese Herbal Medicine as a Complementary Treatment for Neutropenia Prevention and Immunity Modulation During Chemotherapy in Patients With Breast Cancer: Protocol for a Real-World Pragmatic Clinical Trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier BackgroundIn 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. ObjectiveThis 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. MethodsWe 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. ResultsThis 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. ConclusionsTraditional 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. Trial RegistrationInternational Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes International Registered Report Identifier (IRRID)DERR1-10.2196/55662 Medicine R Computer applications to medicine. Medical informatics Hsuan-Shu Shen verfasserin aut Sung-Chao Chu verfasserin aut Tso-Fu Wang verfasserin aut Ching-Wei Lin verfasserin aut Wei-Han Huang verfasserin aut Yi-Feng Wu verfasserin aut Ching-Chun Ho verfasserin aut Cheng-Yoong Pang verfasserin aut Chi-Cheng Li verfasserin aut In JMIR Research Protocols JMIR Publications, 2013 13, p e55662(2024) (DE-627)749502304 (DE-600)2719222-2 19290748 nnns volume:13, p e55662 year:2024 https://doi.org/10.2196/55662 kostenfrei https://doaj.org/article/d55703e1f9864336b57a574fed2933de kostenfrei https://www.researchprotocols.org/2024/1/e55662 kostenfrei https://doaj.org/toc/1929-0748 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13, p e55662 2024
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title	Effectiveness of Chinese Herbal Medicine as a Complementary Treatment for Neutropenia Prevention and Immunity Modulation During Chemotherapy in Patients With Breast Cancer: Protocol for a Real-World Pragmatic Clinical Trial
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title_full	Effectiveness of Chinese Herbal Medicine as a Complementary Treatment for Neutropenia Prevention and Immunity Modulation During Chemotherapy in Patients With Breast Cancer: Protocol for a Real-World Pragmatic Clinical Trial
author_sort	Kai-Hung Wang
journal	JMIR Research Protocols
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author_browse	Kai-Hung Wang Hsuan-Shu Shen Sung-Chao Chu Tso-Fu Wang Ching-Wei Lin Wei-Han Huang Yi-Feng Wu Ching-Chun Ho Cheng-Yoong Pang Chi-Cheng Li
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title_sort	effectiveness of chinese herbal medicine as a complementary treatment for neutropenia prevention and immunity modulation during chemotherapy in patients with breast cancer: protocol for a real-world pragmatic clinical trial
callnumber	R858-859.7
title_auth	Effectiveness of Chinese Herbal Medicine as a Complementary Treatment for Neutropenia Prevention and Immunity Modulation During Chemotherapy in Patients With Breast Cancer: Protocol for a Real-World Pragmatic Clinical Trial
abstract	BackgroundIn 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. ObjectiveThis 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. MethodsWe 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. ResultsThis 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. ConclusionsTraditional 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. Trial RegistrationInternational Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes International Registered Report Identifier (IRRID)DERR1-10.2196/55662
abstractGer	BackgroundIn 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. ObjectiveThis 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. MethodsWe 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. ResultsThis 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. ConclusionsTraditional 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. Trial RegistrationInternational Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes International Registered Report Identifier (IRRID)DERR1-10.2196/55662
abstract_unstemmed	BackgroundIn 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. ObjectiveThis 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. MethodsWe 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. ResultsThis 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. ConclusionsTraditional 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. Trial RegistrationInternational Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes International Registered Report Identifier (IRRID)DERR1-10.2196/55662
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title_short	Effectiveness of Chinese Herbal Medicine as a Complementary Treatment for Neutropenia Prevention and Immunity Modulation During Chemotherapy in Patients With Breast Cancer: Protocol for a Real-World Pragmatic Clinical Trial
url	https://doi.org/10.2196/55662 https://doaj.org/article/d55703e1f9864336b57a574fed2933de https://www.researchprotocols.org/2024/1/e55662 https://doaj.org/toc/1929-0748
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author2	Hsuan-Shu Shen Sung-Chao Chu Tso-Fu Wang Ching-Wei Lin Wei-Han Huang Yi-Feng Wu Ching-Chun Ho Cheng-Yoong Pang Chi-Cheng Li
author2Str	Hsuan-Shu Shen Sung-Chao Chu Tso-Fu Wang Ching-Wei Lin Wei-Han Huang Yi-Feng Wu Ching-Chun Ho Cheng-Yoong Pang Chi-Cheng Li
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up_date	2024-07-04T00:45:29.597Z
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