Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
In head-neck cancer patients undergoing radiotherapy (RT) malnutrition is associated with impaired quality of life, reduced survival, more frequent treatment interruptions and dose reductions. The international guidelines recommend early nutritional support in the presence of nutritional risk, as it allows preventing or treating malnutrition and improving the clinical outcomes, as well as the tolerability of oncologic treatments. Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed head-neck cancer
- •indication to radiotherapy
- •Eastern Cooperative Oncology Group performance status <=2
- •availability to planned measurements and to written informed consent.
排除标准
- •age <18 years
- •ongoing artificial nutrition
结局指标
主要结局
Body weight
时间窗: 6 weeks
Change in body weight at the end of radiotherapy (after 6 weeks)
次要结局
- Quality of life(5 months)
- Handgrip strength(5 months)
- Phase angle(5 months)
- Body weight(5 months)
研究者
Emanuele Cereda
MD, PhD
Fondazione IRCCS Policlinico San Matteo di Pavia
