Herbal composition for treating metastatic breast cancer
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[0026]This study was a randomized, double-blind, placebo-controlled, parallel-group, phase IIa pilot trial in patients with metastatic breast cancer refractory to conventional treatment modalities. The primary outcome was the changes from baseline to post-treatment evaluations in the global health status / quality of life (GHS / QOL) standardized scale, assessed by the self-administered European Organization for Research and Treatment of Cancer Quality of Life Questionnaire—Core 30 (EORTC-QLQ-C30). The secondary outcomes included changes in functional and symptom scales, as well as the single items, of the EORTC-QLC-Q30 and -Breast Cancer 23 (BR23), immunomodulating effects of treatment on lymphocytes, and treatment-related adverse events. The study was approved by the Institutional Review Board (IRB) of the National Taiwan University Hospital, and written informed consents were obtained from all patients prior to entering the trial.
[0027]Participants
[0028]Subjects we...
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