Prospective, Multicenter, Randomized Controlled Study Evaluating the Efficacy of Parenteral Nutrition on the Quality of Life and Overall Survival in Patients in the Palliative Phase of Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 25
- 主要终点
- QLQ-C15-Pal to assess Quality of Life through the physical functioning, Global Health Status and fatigue subscales
研究概览
简要总结
In malnourished patients in the palliative phase of cancer, the question is raised of the relevance of implementing artificial nutritional assistance instead of oral feeding when this is possible.
Medical prescription and implementation of artificial nutrition at this stage of the illness seem less governed by data acquired by science than by subjective reasons (related to beliefs, to a cultural or religious tradition, to the symbolic role of eating, to the deeply ingrained fear of dying of hunger, to a portrayal of care, etc.) while interacting with teams, the patient and his family and relatives.
And yet, the benefits/risk balance and the effect on quality of life of parenteral nutrition in a palliative situation for patients presenting with a normal alimentary tract is poorly understood. The discomfort and risks of central venous or nasogastric artificial nutrition require that the benefits of artificial nutrition be proven. The nature of these benefits relate first and foremost to the quality of life experienced by the patient in such a context. Only a controlled randomized study may lead to an optimal palliative nutritional management of undernutrition to be determined, and to inform the patient and his/her relatives clearly in order for them to express their preferences.
We hypothesize that abstaining from artificial parenteral central venous nutrition and associated hydration for nutritional purposes improves quality of life without significant loss of survival compared to implementing artificial nutrition, when considered, in the absence of any specific curative treatment in anorexic patients in the palliative phase of cancer.
To test this hypothesis, we propose to carry out a multicenter, prospective, controlled, randomized study in order to evaluate the efficacy of implementing parenteral nutrition compared to abstaining from doing so on the quality of life of undernourished patients in the palliative phase of cancer. The effect on overall survival and the nutritional parameters will be evaluated.
The ALIM K trial will be carried out in 13 centres specializing in supportive and onco-hematology care .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- •Any condition that prevents orally feeding (especially patients with cancer of the upper aero-digestive tract, esophagus, obstructive stomach)
- •Peritoneal carcinomatosis if it causes symptoms of sub-occlusion or bowel obstruction
- •Non functional digestive tract (bowel obstruction, tumor compression)
- •Patients with haematological cancers undergoing bonemarrow transplant,
- •Life expectancy is less than 1 month
- •Any contraindications to the parenteral nutrition prescription
- •Parenteral nutrition that is ongoing or dating from less than one month;
- •Presence of gastrostomy or jejunostomy;
- •Persisting sensation of hunger in aphagic patients
- •Patients participating in another ongoing clinical trial Adult
- •Patients under legal guardianship
研究组 & 干预措施
Parenteral nutrition
Parenteral nutrition will be administered to the patients
干预措施: Parenteral nutrition (Other)
Normal per os nutrition
The patients will eat orally
结局指标
主要结局
QLQ-C15-Pal to assess Quality of Life through the physical functioning, Global Health Status and fatigue subscales
时间窗: Time until definitive quality of life score deterioration
The EORTC -The European Organisation for Research and Treatment of Cancer QLQ-C15-Pal - Quality of Life Questionnaire Core 15 Palliative is used. Physical functioning, global health status and fatigue are compared between the 2 groups.
次要结局
- QUAL-E Measuring Quality of Life at the end of Life(Time until definitive quality of life score deterioration)
- Overall survival(Time from randomization to death)
- Body weight(Time until definitive quality of life score deterioration)
- Body Mass Index(Time until definitive quality of life score deterioration)
- Other (non-primary-end point) domains of the QLQ-C15-PAL questionnaire (pain, emotional function, nausea/vomiting, appetite, dyspnea, constipation, and sleep)(Time until definitive quality of life score deterioration)
研究者
Régis AUBRY
Pr
Centre Hospitalier Universitaire de Besancon