JPRN-UMIN000002211已完成2 期
Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: A placebo-controlled double blind randomized Phase II study (The GONE Study) - Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: Randomized Phase II study (The GONE Study)
PO Epidemiological and Clinical Research Information Network (ECRIN)0 个研究点目标入组 80 人开始时间: 2009年7月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •i.Patients who had received blood transfusion, blood products, or hematopoietic growth factors such as granulocyte-colony stimulating factor within 7 days prior to registration. ii.Patients who had used Japanese herbal (Kampo) medicines within 4 weeks before registration. iii.History of severe hypersensitivity (allergy) to any medicines. iv.Prior or current therapy for neuropathy or sensory dysfunction. v.Other active malignancies or a history of other malignancies within the past five years. vi.Uncontrolled pleural effusion or ascites. vii.Pericardial effusion. viii.A systemic inflammatory condition or serious infection. ix.Symptomatic brain metastasis. x.Significant electrocardiographic abnormality. xi.Clinically problematic cardiac disease (congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, or myocardial infarction within the past 12 months). xii.Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema, etc.). xiii.Gastrointestinal bleeding that requires medication or transfusion. xiv.Diarrhea (watery) or diarrhea that interferes with daily activities for patients with a stoma. xv.Ileus or bowel obstruction. xvi.Central nervous system disorders. xvii.Senile dementia. xviii.Serious psychological disease. xix.Uncontrolled diabetes mellitus with or without diabetic neuropathy. xx.Pregnant or lactating women. xxi.Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
研究者
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