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Karnofsky Performance Status as A Predictive Factor for Cancer-Related Fatigue Treatment with Astragalus Polysaccharides (PG2) Injection—A Double Blind, Multi-Center, Randomized Phase IV Study

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Division of Hematology/Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Keelung 204, Taiwan
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Chi Mei Medical Center, Liouying, Tainan City 736, Taiwan
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Department of Hematology/Oncology, Linkou Chang Gung Memorial Hospital, Taoyuan 333, Taiwan
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College of Medicine, Chang Gung University, Taoyuan 333, Taiwan
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Tri-Service General Hospital, Taipei 114, Taiwan
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Hematology-Oncology Division, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 833, Taiwan
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Hematology-Oncology Department, E-Da Cancer Hospital, Kaohsiung 824, Taiwan
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Collage of Medicine, I-Shou University, Kaohsiung 824, Taiwan
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Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei 11031, Taiwan
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Department of Radiation Oncology, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan
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Changhua Christian Hospital, Changhua County 500, Taiwan
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China Medical University Hospital, Taichung City 40447, Taiwan
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Phytohealth Co., Taipei 105, Taiwan
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MacKay Memorial Hospital, New Taipei City 25160, Taiwan
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Mackay Medical College, New Taipei City 25245, Taiwan
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Author to whom correspondence should be addressed.
Cancers 2019, 11(2), 128; https://doi.org/10.3390/cancers11020128
Received: 22 October 2018 / Revised: 2 January 2019 / Accepted: 15 January 2019 / Published: 22 January 2019
Fatigue is a common and debilitating symptom in patients with advanced cancer, resulting in poor quality of life and reduced treatment efficacy. Phytotherapeutic agents have shown potential effects to relieve cancer-related fatigue in these patients. The aim of this study was to evaluate the efficacy and safety of Astragalus Polysaccharides injection and identify predictive factors associated with this treatment. Patients with advanced cancer receiving palliative care with moderate to severe cancer-related fatigue were enrolled in this study for two treatment cycles. Fatigue improvement response rates were analyzed as the primary endpoint at the end of the first cycle to determine treatment efficacy. The drug safety profile was evaluated by the reporting of adverse events. Three hundred and ten patients were enrolled in this study and 214 patients were included ITT population. Improvement in fatigue scores by at least 10% was observed in greater than 65% of subjects after one treatment cycle compared to scores at baseline. Patients with higher Karnofsky Performance Status (KPS) responded better to the Astragalus Polysaccharides injection. Drug-related adverse event rates were less than 9%. This study identified KPS as a promising predictive factor for the therapeutic efficacy of Astragalus Polysaccharides injection. View Full-Text
Keywords: eywords: astragalus polysaccharides; fatigue; cancer; palliative care; KPS eywords: astragalus polysaccharides; fatigue; cancer; palliative care; KPS
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MDPI and ACS Style

Wang, C.-H.; Lin, C.-Y.; Chen, J.-S.; Ho, C.-L.; Rau, K.-M.; Tsai, J.-T.; Chang, C.-S.; Yeh, S.-P.; Cheng, C.-F.; Lai, Y.-L. Karnofsky Performance Status as A Predictive Factor for Cancer-Related Fatigue Treatment with Astragalus Polysaccharides (PG2) Injection—A Double Blind, Multi-Center, Randomized Phase IV Study. Cancers 2019, 11, 128. https://doi.org/10.3390/cancers11020128

AMA Style

Wang C-H, Lin C-Y, Chen J-S, Ho C-L, Rau K-M, Tsai J-T, Chang C-S, Yeh S-P, Cheng C-F, Lai Y-L. Karnofsky Performance Status as A Predictive Factor for Cancer-Related Fatigue Treatment with Astragalus Polysaccharides (PG2) Injection—A Double Blind, Multi-Center, Randomized Phase IV Study. Cancers. 2019; 11(2):128. https://doi.org/10.3390/cancers11020128

Chicago/Turabian Style

Wang, Cheng-Hsu, Cheng-Yao Lin, Jen-Shi Chen, Ching-Liang Ho, Kun-Ming Rau, Jo-Ting Tsai, Cheng-Shyong Chang, Su-Peng Yeh, Chieh-Fang Cheng, and Yuen-Liang Lai. 2019. "Karnofsky Performance Status as A Predictive Factor for Cancer-Related Fatigue Treatment with Astragalus Polysaccharides (PG2) Injection—A Double Blind, Multi-Center, Randomized Phase IV Study" Cancers 11, no. 2: 128. https://doi.org/10.3390/cancers11020128

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