Effect of Very Low Carbohydrate Diet to Glasgow Prognostic Score, Serum Lactate and TNF Alpha on Colorectal Cancer Patients With Best Supportive Care
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 主要终点
- Glasgow Prognostic Score
研究概览
简要总结
This study examine the effects of very low carbohydrate diet (in which the calories requirements are mostly from fat) to the level of systemic inflammation (measured by Glasgow Prognostic Score), serum lactate and TNF Alpha levels
详细描述
This study examine the effects of very low carbohydrate diet (in which the calories requirements are mostly from fat) to the level of systemic inflammation (measured by Glasgow Prognostic Score), serum lactate and TNF Alpha levels. The subjects are colorectal adenocarcinoma patients who were decided by experts to be managed by best supportive care. These patients are not deemed to be suitable for surgical intervention , chemotherapy or radiotherapy anymore. The main treatment is supportive. We would like to examined the effect of very low carbohydrate diet on these patients, in which theoretically tumtor cells of the colorectal adenocarcinoma needed glucose to replicate and increases the systemic inflammation response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
Care provider are not told whether the patient belongs to intervention or control group
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as colorectal adenocarcinoma pathologically
- •Decided by a digestive surgery consultant to be managed with best supportive care
- •More than 17 years old and capable of making informed consent
- •Karnofsky score > 50% or ECOG performance status <=2
- •No clinical signs of infection, with one or more of these criteria : fever, leukocytosis, local sign of infection (eg.abscess,ulcer)
- •AST < 2 times normal limit
- •ALT < 2 times normal limit
- •Serum Creatinine < 1,5 times normal limit
- •Not pregnant (for women)
- •Able to understand and willing participate and to sign informed consent form
- •No Diabetes Mellitus
- •No fat intolerance
- •No severe malnutrition or cancer cachexia
排除标准
- •Patient is still on other therapy for the tumour
- •Patient with coexisting diseases which prohibits the patient to follow the study protocols
研究组 & 干预措施
Very Low Carbohydrate Diet
The patient will be evaluated for baseline clinical and laboratory values, and counselled on very low carbohydrate diet.
干预措施: Very Low Carbohydrate Diet (Other)
Control
The patient will be evaluated for baseline clinical and laboratory values, and counselled on normal healthy .
结局指标
主要结局
Glasgow Prognostic Score
时间窗: Change of baseline Glasgow Prognostic Score on day 21
A score to evaluate systemic inflammation response
次要结局
- Serum Lactate(Change of baseline Serum Lactate on day 21)
- TNF Alpha(Change of baseline TNF Alpha serum level on day 21)