safety and efficacy of tien-hsien liquid practical in patients with refractory metastatic breast cancer: a randomized, double-blind, placebo-controlled, parallel-group, phase iia trial
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2012
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Abstract
To evaluate the safety and efficacy of Tien-Hsien Liquid Practical (THL-P), a Chinese herbal mixture, in patients with refractory metastatic breast cancer, we performed a randomized, double-blind, placebo-controlled, parallel-group, phase IIa pilot trial. Patients were randomly assigned to either receive THL-P or matching placebo and followed up every 4 weeks for 24 weeks. The primary endpoint was changes in the global health status/quality of life (GHS/QOL) scale. The secondary endpoints were changes in functional and symptom scales, immunomodulating effects, and adverse events. Sixty-three patients were enrolled between June 2009 and June 2011. The intent-to-treat population included 28 patients in the THL-P group and 11 patients in the placebo group. Compared to the placebo group, the THL-P group had significant improvement from baseline to last visit in GHS/QOL (41.7 versus −33.3; P<0.05), CD3, CD4/CD8, CD19, CD16+56 positive cells (P<0.05), and higher levels of physical, role, emotional, and cognitive functioning, as well as decreased fatigue and systemic side effects. Treatment-related adverse events were mild constipation and localized itching, and no serious adverse events were reported. THL-P appears to be a safe alternative adjuvant treatment for patients with refractory metastatic breast cancer, as it effectively improves QOL and palliates cancer-related symptoms.
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| Reference Key |
kuo2012evidence-basedsafety
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|---|---|
| Authors | ;Wen-Hung Kuo;Chien-An Yao;Chih Hui Lin;King-Jen Chang |
| Journal | ACS applied materials & interfaces |
| Year | 2012 |
| DOI |
10.1155/2012/803239
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| URL | |
| Keywords |
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