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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
106
Administration of standard intravenous nutritional products. The products are commonly used in the department where the research is conducted
Palliative Care Unit - CHU Jean Minjoz
Besançon, France
Centre François Baclesse
Caen, France
Centre hospitalier Henri Mondor
Créteil, France
Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
Institut Paoli calmettes
Marseille, France
Hopital de la Timone
Marseille, France
Institut Curie
Paris, France
Insitut Jean Godinot
Reims, France
...and 3 more locations
QLQ-C15-Pal to assess Quality of Life through the physical functioning, Global Health Status and fatigue subscales
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.
Time frame: Time until definitive quality of life score deterioration
QUAL-E Measuring Quality of Life at the end of Life
Questionaire for patients who believe they are nearing the end of life and comparison between the 2 groups.
Time frame: Time until definitive quality of life score deterioration
Overall survival
Comparison of overall survival between the 2 groups
Time frame: Time from randomization to death
Other (non-primary-end point) domains of the QLQ-C15-PAL questionnaire (pain, emotional function, nausea/vomiting, appetite, dyspnea, constipation, and sleep)
Comparison of other domains of the QLQ-C15-PAL questionnaire between the 2 groups.
Time frame: Time until definitive quality of life score deterioration
Body weight
Body weight will be compared between the 2 groups .
Time frame: Time until definitive quality of life score deterioration
Body Mass Index
Body Mass Index will be compared between the 2 groups .
Time frame: Time until definitive quality of life score deterioration
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