Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Frequency and grade of mucositis
研究概览
简要总结
The aim of this study is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet [Impact (R), Novartis] versus a standard enteral nutrition (control, Novartis), could improve clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status, and life quality parameters.
详细描述
Malnutrition is frequent in head and neck (H&N) and esophageal cancers and alters immune status, anti-infectious and anti-tumoral defenses and the response to the treatment (surgery, chemotherapy, radiotherapy). Treatment of these 2 types of cancer is often chemoradiotherapy which frequently induces mucositis. Mucositis enhances nutritional risk and could impose a modification or an interruption of the treatment. The aim of this study is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet [Impact(R), Novartis] versus a standard enteral nutrition (control, Novartis), could improve clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status, and life quality parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •H&N and esophageal cancer patients, not treated by surgery and needing chemoradiotherapy
- •Performance status: Objective Mucositis Score (OMS) of 0, 1, 2 or Karnofsky > 50%
- •Acceptance of a gastrostomy, jejunostomy or a nasogastric tube to conduct enteral nutrition
- •Informed consent form signed
排除标准
- •H&N cancer treated by exclusive radiotherapy
- •H&N and esophageal cancer which can be treated by exclusive surgery
- •Tonsil cancer
- •Existence of metastases
- •Concomitant cancer
- •Repeat of cancer at site
- •Insulin dependant diabetes
- •Thyroid diseases
- •Subjects with major surgery or severe infectious status in the 3 preceding months
- •Biological assessment incompatible with the esophagus chemotherapy treatment (polynuclear cells < 1500/ml; blood platelets < 100000/ml; serum creatinine > 130 µmol/ml; ASAT, ALAT, ALP and bilirubin > twice the norm)
- •Patients taking food or supplements enriched with omega 3 (arginine and nucleotides), during the period of the study and in the preceding month
- •Breast feeding women or in period of fertility without effective means of contraception
- •Patients who refuse to participate or are unable to receive information or are unable to sign written informed consent.
研究组 & 干预措施
nutrition
study of immuno-modulating enteral nutrition
干预措施: Impact (R) Enteral Nutrition (Dietary Supplement)
nutrition
study of immuno-modulating enteral nutrition
干预措施: impact (Other)
结局指标
主要结局
Frequency and grade of mucositis
时间窗: each visit
次要结局
- Other complications linked to chemoradiotherapy(each week of chemoradiotherapy)
- Effect on treatment conditions (interruption, doses)(each visit)
- Nutritional and immune status(at randomisation's visit, visit at the end of treatment, 1, 6 and 12 months after the end of treatment)
- Life quality(at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment)
- Cost(each visit)