The Effect of Vitamin C on Quality of Life of Terminal Cancer Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The improvement of quality of life (QOL)
研究概览
简要总结
This study determines whether high dose vitamin C is effective for quality of life in terminal cancer patients.
详细描述
The investigator's project is a single medical center, randomized double- blinded trial. The target group is terminal cancer patients at Palliative care clinics. The experimental group will receive intravenous high-dose vitamin C 30 g in 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. The control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. The primary outcome is the improvement of quality of life, measured by European Organization for Research and Treatment of cancer (EORTC). The secondary outcome is the survival analysis.The participants will be followed up weekly for 2 weeks, then bi-weekly for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
double-blinded
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Terminal colon cancer patients without pleural effusions, who will not receive any curative radiotherapy or chemotherapy.
排除标准
- •Renal metastasis or obstructive uropathy by radiology
- •Nephrotic syndrome
- •Creatinine over 1.5mg/dl
- •Urolithasis
- •Under other folk therapy or vitamin infusion therapy
- •Those who can't exercise the right of consent
- •Those who can't answer the questionaires
- •Glucose-6-Phosphate Dehydrogenase Deficiency
- •Severe lower leg edema or general edema
研究组 & 干预措施
The study group
The study group will receive intravenous high-dose vitamin C 30 gm in 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment.
干预措施: high-dose vitamin C 30gm (Drug)
The study group
The study group will receive intravenous high-dose vitamin C 30 gm in 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment.
干预措施: normal saline (Other)
The control group
The control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment.
干预措施: normal saline (Other)
结局指标
主要结局
The improvement of quality of life (QOL)
时间窗: 6 months
QOL measured by European Organization for Research and Treatment of cancer Quality of Life Questionnaire (EORTC QLQ)-C30
次要结局
- Survival analysis(6 months)