Clinical trial · Interventional
Efficacy of Parenteral Nutrition in Patients at the Palliative Phase of Cancer.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| End Stage Cancer | — | UNRESOLVED | — |
| Nutrition Aspect of Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Parenteral nutrition | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Parenteral nutrition
- description
- Parenteral nutrition will be administered to the patients
- interventionNames
- Other: Parenteral nutrition
- type
- NO_INTERVENTION
- label
- Normal per os nutrition
- description
- The patients will eat orally
Primary outcomes (1)
- measure
- QLQ-C15-Pal to assess Quality of Life through the physical functioning, Global Health Status and fatigue subscales
- timeFrame
- Time until definitive quality of life score deterioration
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria are: * adult patients (aged \>18 years) suffering from cancer at the palliative stage, i.e. patients in whom the main aim of treatment is to limit pain and discomfort * curative treatment has either been discontinued, or may still be ongoing but with little expected benefit in terms of overall survival * patients must already have a functional central venous catheter in place * present malnutrition defined as a body mass index (BMI) \<18.5 kg/m² in patients aged \<70 years or \<21 kg/m² in patients aged ≥70 years; or weight loss of 2% in 1 week, 5% in 1 month, or 10% in 6 months * patients must have a functional digestive tract * patients able to express themselves easily in French and answer questionnaires Exclusion Criteria: * 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
References
Publications (2)
- BACKGROUNDPazart 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. PMID 25248371
- DERIVEDBouleuc 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. PMID 41534624