跳至主要内容
临床试验/NCT02055833
NCT02055833已完成不适用

Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy: a Randomized, Controlled Trial

Fondazione IRCCS Policlinico San Matteo di Pavia2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2013年9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
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

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

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emanuele Cereda

MD, PhD

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (2)

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