NCT01871155已完成不适用
Efficacy Study of Nutri-jelly Intake on Quality of Life in Head and Neck Cancer Patients Undergoing Radiotherapy
Dental Innovation Foundation Under Royal Patronage2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2012年1月1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
- 64
- 试验地点
- 2
- 主要终点
- Changes in Health-related quality of life score
研究概览
简要总结
The purpose of this study is to determine whether a novel edible nutritious gel for patients with chewing and swallowing difficulties, Nutri-jelly, is effective in improving the quality of life of head and neck cancer patients while undergoing conventional radiotherapy.
详细描述
- independent variable: continuous Nutri -jelly intake
- dependent variable (outcome): changes in health-related quality of life score
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as head and neck cancer
- •definitive or palliative radiotherapy treatment plan
- •can communicate well
排除标准
- •bleeding in the mouth
- •respiratory distress
- •psychiatric disorders
- •radiation field not involve masticatory and swallowing apparatus e.g. certain cases of laryngeal cancer and brain cancer
结局指标
主要结局
Changes in Health-related quality of life score
时间窗: 0, 1, 2, 3, 4, 5, 6 weeks after radiotherapy
* Definitive cases: collect data at baseline (0-5), after Nutri-jelly (6-10), 11-15, 16-20, 21-25, 26-30, 31-35 fractions of RT), total period of 6 weeks * Palliative cases: collect data at baseline (0-5), after Nutri-jelly (6-10) fractions of RT, total period of 2 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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