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Fuzheng Kang’ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial

BACKGROUND: Patients with advanced non-small cell lung cancer (NSCLC) harboring mutations of the epidermal growth factor receptor (EGFR) gene respond well to the EGFR tyrosine kinase inhibitor (TKI) gefitinib. Chinese herbal medicine (CHM) has been used as a complementary therapy for cancer for deca...

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Autores principales: Yang, Xiao-Bing, Wu, Wan-yin, Long, Shun-qin, Deng, Hong, Pan, Zong-Qi, He, Wen-Feng, Zhou, Yu-Shu, Liao, Gui-Ya, Li, Qiu-Ping, Xiao, Shu-Jing, Cai, Jiao-Zhi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4396173/
https://www.ncbi.nlm.nih.gov/pubmed/25873045
http://dx.doi.org/10.1186/s13063-015-0685-2
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author Yang, Xiao-Bing
Wu, Wan-yin
Long, Shun-qin
Deng, Hong
Pan, Zong-Qi
He, Wen-Feng
Zhou, Yu-Shu
Liao, Gui-Ya
Li, Qiu-Ping
Xiao, Shu-Jing
Cai, Jiao-Zhi
author_facet Yang, Xiao-Bing
Wu, Wan-yin
Long, Shun-qin
Deng, Hong
Pan, Zong-Qi
He, Wen-Feng
Zhou, Yu-Shu
Liao, Gui-Ya
Li, Qiu-Ping
Xiao, Shu-Jing
Cai, Jiao-Zhi
author_sort Yang, Xiao-Bing
collection PubMed
description BACKGROUND: Patients with advanced non-small cell lung cancer (NSCLC) harboring mutations of the epidermal growth factor receptor (EGFR) gene respond well to the EGFR tyrosine kinase inhibitor (TKI) gefitinib. Chinese herbal medicine (CHM) has been used as a complementary therapy for cancer for decades in China. CHM was proved to be effective in improving the quality of life (QOL) and reducing the toxicity associated with chemotherapy in patients with NSCLC. The purpose of the present trial is to determine whether CHM (Fuzheng Kang’ai decoction (FZKA), a CHM formula) combined with gefitinib results in longer progression-free survival with less toxicity than gefitinib alone. METHODS/DESIGN: This is a randomized, placebo-controlled, double-blind trial. This trial is designed to determine if CHM (FZKA) combined with gefitinib results in longer progression-free survival with less toxicity than gefitinib alone. A total of 70 NSCLC patients with EGFR mutations will be randomly assigned to treatment group (gefitinib plus FZKA granules) or control group (gefitinib plus placebo). The primary endpoint is progression-free survival. Secondary endpoints are: (1) overall survival; (2) disease control rate; (3) QOL, measured with the questionnaire of Functional Assessment of Cancer Therapy-lung (FACT-L 4.0) and Lung Cancer Symptom Scale and (4) safety. DISCUSSION: In previous clinical practice, we found that CHM (FZKA) could improve the therapeutic efficacy of gefitinib. This study will provide objective evidence to evaluate the efficiency of CHM combined with gefitinib in NSCLC patients with EGFR mutations, and may provide a novel regimen for patients with NSCLC. TRIAL REGISTRATION: Chinese Clinical Trial Registry (www.chictr.org): ChiCTR-IOR-14005679, registered 17 December 2014.
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spelling pubmed-43961732015-04-15 Fuzheng Kang’ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial Yang, Xiao-Bing Wu, Wan-yin Long, Shun-qin Deng, Hong Pan, Zong-Qi He, Wen-Feng Zhou, Yu-Shu Liao, Gui-Ya Li, Qiu-Ping Xiao, Shu-Jing Cai, Jiao-Zhi Trials Study Protocol BACKGROUND: Patients with advanced non-small cell lung cancer (NSCLC) harboring mutations of the epidermal growth factor receptor (EGFR) gene respond well to the EGFR tyrosine kinase inhibitor (TKI) gefitinib. Chinese herbal medicine (CHM) has been used as a complementary therapy for cancer for decades in China. CHM was proved to be effective in improving the quality of life (QOL) and reducing the toxicity associated with chemotherapy in patients with NSCLC. The purpose of the present trial is to determine whether CHM (Fuzheng Kang’ai decoction (FZKA), a CHM formula) combined with gefitinib results in longer progression-free survival with less toxicity than gefitinib alone. METHODS/DESIGN: This is a randomized, placebo-controlled, double-blind trial. This trial is designed to determine if CHM (FZKA) combined with gefitinib results in longer progression-free survival with less toxicity than gefitinib alone. A total of 70 NSCLC patients with EGFR mutations will be randomly assigned to treatment group (gefitinib plus FZKA granules) or control group (gefitinib plus placebo). The primary endpoint is progression-free survival. Secondary endpoints are: (1) overall survival; (2) disease control rate; (3) QOL, measured with the questionnaire of Functional Assessment of Cancer Therapy-lung (FACT-L 4.0) and Lung Cancer Symptom Scale and (4) safety. DISCUSSION: In previous clinical practice, we found that CHM (FZKA) could improve the therapeutic efficacy of gefitinib. This study will provide objective evidence to evaluate the efficiency of CHM combined with gefitinib in NSCLC patients with EGFR mutations, and may provide a novel regimen for patients with NSCLC. TRIAL REGISTRATION: Chinese Clinical Trial Registry (www.chictr.org): ChiCTR-IOR-14005679, registered 17 December 2014. BioMed Central 2015-04-10 /pmc/articles/PMC4396173/ /pubmed/25873045 http://dx.doi.org/10.1186/s13063-015-0685-2 Text en © Yang et al.; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Yang, Xiao-Bing
Wu, Wan-yin
Long, Shun-qin
Deng, Hong
Pan, Zong-Qi
He, Wen-Feng
Zhou, Yu-Shu
Liao, Gui-Ya
Li, Qiu-Ping
Xiao, Shu-Jing
Cai, Jiao-Zhi
Fuzheng Kang’ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial
title Fuzheng Kang’ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial
title_full Fuzheng Kang’ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial
title_fullStr Fuzheng Kang’ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial
title_full_unstemmed Fuzheng Kang’ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial
title_short Fuzheng Kang’ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial
title_sort fuzheng kang’ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4396173/
https://www.ncbi.nlm.nih.gov/pubmed/25873045
http://dx.doi.org/10.1186/s13063-015-0685-2
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