ACTRN12615001277538已完成不适用
A clinical window study in colorectal cancer patients to assess the effects of high dose vitamin C administration on tumour biology
Prof Margreet Vissers0 个研究点目标入组 12 人开始时间: 2015年11月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Confirmed colorectal cancer (via biopsy histology) and scheduled to undergo surgery
- •2.Good physical functional status – ECOG grade 0 or 1
- •3.Aged >/= 18 years
- •4.Able to give informed consent to participate in the study
- •5.Signed informed consent to donate tissue (biopsy tissue and surplus tissue from surgery) and blood samples
- •6.Adequate bone marrow, hepatic, renal and cardiac function
- •7.Able to come to the clinical research unit four times in the week prior to surgery for IV infusions
排除标准
- •1.Receiving neoadjuvant therapy
- •2.Supplementing with vitamin C >/= 1g/d
- •3.Serum creatinine concentration >175 µmol/L
- •4.Erythrocyte glucose-6-phosphate dehydrogenase activity deficiency
- •5.Serious gastrointestinal disorders including active bleeding
- •6.Patients with serious or uncontrolled infection, cardiac or neurological conditions
- •7.Dementia or altered mental status that would render informed consent impossible
- •8.Pregnant or lactating women
- •9.Any abnormal laboratory value or medical condition that would, in the investigators’ judgement, make the patient a poor candidate for the study
- •10.Current calcium oxalate nephropathies with the potential to block urinary flow
- •11.Adverse response to test dose of 25 g IV vitamin C given on the first intervention day
- •12.Individuals with diabetes as HDVC can have a hypoglycaemic effect and can also interfere with some glucose finger stick devices
研究者
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