ACTRN12615000889550已完成2 期
Investigating whether, in patients receiving breast cancer surgery, pre-operative Propranolol compared with placebo, changes the cancer's gene expression.
Peter MacCallum Cancer Centre0 个研究点目标入组 64 人开始时间: 2015年8月25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
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- Female
入选标准
- •Written, informed consent;
- •-Female subjects with histologically-confirmed breast cancer, who will undergo surgical excision at PMCC at least 7 days after enrollment;
- •-Age 18-80 years old;
- •-World Health Organization ECOG performance status 0 or 1;
排除标准
- •-Women who are pregnant or breast feeding;
- •-Women with absolute or relative contraindications to Propranolol:
- •Sick sinus syndrome.
- •Sinus bradycardia (less than 60 beats/minute).
- •First, Second or third degree atrioventricular block.
- •Resting blood pressure less than 100/60mmHg.
- •Untreated phaeochromocytoma
- •Untreated thyroid disorder
- •Patients receiving dihydropyridine or non-dihydropyridine Calcium Channel Blocking agents (eg diltiazem, verapamil, nifedipine, amlodipine)
- •Severe peripheral vascular disease (intermittent claudication)
- •Patients receiving anti-arrhythmic agents (eg amiodarone, sotalol, digoxin)
- •Patients with renal impairment (defined as Creatinine greater than 0.15mmol/L)
- •Patients with liver impairment: AST or ALT or ALP > 2.5 x upper limit of normal range (ULN), bilirubin > 1.5 x ULN, ALP > 2.5.
- •Patients receiving Clonidine, Digoxin, Rizatriptan, Cimetidine, Hydralazine, Guanethidine or Ergotamine
- •Episodes of major depression
- •-Breast resection within 6 months of study entry;
- •-Women who have received neoadjuvant chemotherapy prior to the planned breast cancer resection;
- •-Women with histologically demonstrated ductal carcinoma in situ;
- •-Non-English speaking women;
- •-Women using regular (daily) pre-operative anti-inflammatory agents eg NSAIDs and aspirin >100mg/day;
- •-Women using regular anxiolytics (eg benzodiazepines), alpha-receptor adrenergic agonists (eg Clonidine);
- •-Use of selective or non-selective beta-adrenergic inhibitors in the last three months (examples include Propranolol, Metoprolol, Atenolol, Sotalol);
- •-Past history of stroke;
- •-Women with moderate or severe asthma, as defined by previous Intensive Care Unit admission or oral steroid-requiring asthma;
- •-Other medical conditions considered prohibitive by the treating physician (including frailty).
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