JPRN-jRCT1041190019暂停2 期
A phase II randomized clinical trial to determine the effectiveness of goreisan and saireito for lower limb lymphedema in women treated for gynecologic cancer
Kajiyama Hiroaki0 个研究点目标入组 40 人开始时间: 2019年4月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1) Patients who underwent uterine malignancy surgery including retroperitoneal lymph node dissection or surgical operation of the uterine appendix malignant tumor by preoperative diagnosis of gynecological malignancy
- •2) Patients diagnosed with secondary lymphedema in 1)
- •3) Patients with ECOG-PS 0 or 1
- •4) Patients whose main organ functions are adequately maintained
- •(A) White blood cell count 3,500 / mm 3 12 000 / mm 3
- •(B) Number of neutrophils 1,500 / mm 3
- •(C) Number of platelets 100,000 / mm 3
- •(D) Hb 9.0 g / dL
- •(E) AST,ALT 100 IU / L
- •(F) Creatinine 1.2 mg / dL
- •5) Patients whose age at registration is 20 years or older
- •6) Patients who have obtained document consent
排除标准
- •1) Patients who are allergic to the ingredients of traditional Chinese medicine or goriso-san/saireito
- •2) Patients with severe complications (heart failure, renal failure, liver failure, hypoactive nutrition etc.) and severe mental illness
- •3) Patients whose oral ingestion is impossible
- •4) Patients diagnosed with primary lymphedema
- •5) Patients with lower extremity vein thrombosis
- •6) In addition, patients judged unsuitable for doctors to safely carry out this study
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