A Pilot pharmacokinetic study of the interaction between two systemic Complementary and Alternative Medicines and standard therapy in patients with active breast cancer malignancy

Gregory Peterson0 个研究点目标入组 20 人开始时间: 2015年6月29日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Participants had active (locally advanced/recurrent or metastatic) breast cancer and had been taking a stable once daily oral dose of either letrozole (2.5mg) or tamoxifen (20mg) for a minimum of four weeks prior to the study, to ensure steady-state had been achieved, with at least three weeks of therapy remaining in their treatment course. Other inclusion criteria were as follows: aged greater than or equal to 18 years; able to complete documentation of the treatment and adverse events, and attend follow-up; and able to swallow capsules whole.

•Patients were excluded if they met any of the following criteria: reluctance or inability to cease other CAM at least a week prior to trial commencement; ECOG performance of greater than or equal to 3; life expectancy of less than or equal to 12 weeks; impaired haematopoietic (WBC < 3.0 x 109/L, ANC < 1.5 x 109/L, platelet < 100 x 109/dL), renal (GFR < 50mL/min) or hepatic function (either AST/ALT > 2.5 ULN, or > 5 x ULN in case of liver metastases, or bilirubin > 1.5 x ULN); pregnancy or lactation; cerebral or leptomeningeal metastases that were unstable in spite of appropriate therapy; serious intercurrent illness; major surgery within two weeks prior to study commencement; concurrent radiotherapy; bowel obstruction; documented allergy to fucoidan; concurrent warfarin therapy; and participation in trials of other pharmacological agents during the time of this study.

发起方

Gregory Peterson