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临床试验/NCT02900963
NCT02900963已完成不适用

Nutritional Assessment of Locally Advanced Head and Neck Cancer Patients Who Underwent Exclusive or Adjuvant Radiotherapy or Chemo-radiotherapy

Centre Henri Becquerel2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
280
试验地点
2
主要终点
weight

研究概览

简要总结

Radiotherapy and chemotherapy are standard treatment of head and neck cancer alone or associated to surgical treatment. Early (during treatment or the following weeks) and late side effects contribute to malnutrition in this population at risk. In this context, nutritional support adapted by dietary monitoring and enteral nutrition (nasogastric tube or gastrostomy) are often necessary. The early identification of the patients with high malnutrition risk and requiring enteral nutrition is necessary to improve the tolerance and efficacy of treatment. This prospective study research the factors of malnutrition during head and neck radiotherapy.

详细描述

Head and neck cancer is one of the most common malignancies in the world, Malnutrition occurs frequently at the time of diagnosis as consequences of alcohol consumption and tobacco use that is quite common in this patients population, and of local tumor invasion, obstructing the function of swallowing and chewing. In addition, during the treatment, mucositis, anorexia, dysphagia, mouth sores, and other acute and late toxic effects of radiotherapy (RT) and chemotherapy frequently worsen the nutritional status.

Poor nutritional status and chemotherapy or RT-toxicity, lead to treatment interruption frequently and is also associated with higher risk of infection, hospital readmission, early death, worse survival outcomes, and deterioration in the quality of life (QoL). According to published results, one third of the patient would have benefit from a complete treatment. In addition, the correlation exists between some biological parameters (CRP, albumin, neutrophils, Hb) and the nutritional status. Therefore, it deems essential to maintain nutritional status in head and neck cancer patients undergoing RT and chemotherapy.

Dietary counseling and oral supplements showed positive influences on nutritional outcomes and QoL However, their role is limited when it comes to obstruction or mucositis. Thus, enteral feeding may be a choice either through nasogastric tube (NGT) or percutaneous endoscopic gastrostomy (PEG). Studies investigated the effects of PEG compared with NGT were not conclusive or showing no consistent results on nutritional status, treatment interruption, nutrition-related hospital admission, and tube-related complications in the head and neck cancer patients receiving RT or chemo-radiotherapy.

The optimal method and the timing of placement are still debated. Consequently, the aim of this study is to collect data on our current daily practice on supplementary nutrition method ( NGT, PEG) in head and neck cancers patients treated in our radiation therapy unit and to identify factors predicting good treatment outcomes( ie full treatment administration).

Secondary objectives are to collect nutritional data during the treatment, to study the nutritional status in relation to acute or late adverse events, to study the impact of an early enteral feeding on clinical and biological parameters.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Males or females older than 18 years
  • Performance Status 0 or 1 or 2
  • Locally advanced head and neck cancer treated with a curative intent treatment consisting of either concomitant chemo-radiotherapy or adjuvant radiation therapy or adjuvant chemo-radiotherapy.
  • Signed Informed Consent

排除标准

  • Other cancer or previous cancer within 2 years or evolutive cancer
  • Performance Status 3 or 4
  • NGT or PEG at screening period
  • Any legal, social, psychological reasons that could jeopardize the patient's compliance to the study constrains.

结局指标

主要结局

weight

时间窗: one year

Measure of weight ( in Kg)

次要结局

  • BMI calculation(one year)
  • Nutritional status determination(One year)
  • Inflammatory status(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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