Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut Curie | OTHER |
| Institut de Cancérologie de Lorraine | OTHER |
| Centre Paul Strauss | OTHER |
| Institut Jean-Godinot |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 .
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parenteral nutrition | Experimental | Parenteral nutrition will be administered to the patients |
|
| Normal per os nutrition | No Intervention | The patients will eat orally |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenteral nutrition | Other | Administration of standard intravenous nutritional products. The products are commonly used in the department where the research is conducted |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 until definitive quality of life score deterioration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 until definitive quality of life score deterioration |
| Overall survival |
Not provided
Inclusion criteria are:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Regis Aubry, Prof. | Centre Hospitalier Universitaire de Besancon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palliative Care Unit - CHU Jean Minjoz | Besançon | 25000 | France | |||
| Centre François Baclesse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25248371 | Background | Pazart L, Cretin E, Grodard G, Cornet C, Mathieu-Nicot F, Bonnetain F, Mercier M, Cuynet P, Bouleuc C, Aubry R; ALIM-K study investigational group. Parenteral nutrition at the palliative phase of advanced cancer: the ALIM-K study protocol for a randomized controlled trial. Trials. 2014 Sep 24;15:370. doi: 10.1186/1745-6215-15-370. | |
| 41534624 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D010288 | Parenteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
Not provided
Not provided
| OTHER |
| Gustave Roussy, Cancer Campus, Grand Paris | OTHER |
| Institut Paoli-Calmettes | OTHER |
| Centre Leon Berard | OTHER |
| Henri Mondor University Hospital | OTHER |
| Centre Oscar Lambret | OTHER |
| Centre Georges Francois Leclerc | OTHER |
| Centre Francois Baclesse | OTHER |
| Hôpital de la Timone (MARSEILLE) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Comparison of overall survival between the 2 groups
| 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 until definitive quality of life score deterioration |
| Body weight | Body weight will be compared between the 2 groups . | Time until definitive quality of life score deterioration |
| Body Mass Index | Body Mass Index will be compared between the 2 groups . | Time until definitive quality of life score deterioration |
| Caen |
| 14000 |
| France |
| Centre hospitalier Henri Mondor | Créteil | 94010 | France |
| Centre Georges François Leclerc | Dijon | 21000 | France |
| Centre Oscar Lambret | Lille | 59000 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Institut Paoli calmettes | Marseille | 13009 | France |
| Hopital de la Timone | Marseille | France |
| Institut Curie | Paris | 75005 | France |
| Insitut Jean Godinot | Reims | 51100 | France |
| Centre Paul Strauss | Strasbourg | 67065 | France |
| Centre de cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54500 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Bouleuc C, Garabige V, Grodard G, Anota A, Aubry R, Marchal T. Impact of parenteral nutrition on oral intake and eating pleasure in advanced cancer patients: A sub-analysis of a multicenter randomized controlled trial. Clin Nutr ESPEN. 2026 Apr;72:102905. doi: 10.1016/j.clnesp.2025.102905. Epub 2026 Jan 12. |
| D009750 | Nutritional and Metabolic Diseases |