Efficacy of Parenteral Nutrition in Patients at the Palliative Phase of Cancer.

NCT02151214 | Completed DMC

• 1 other identifier: ALIM-K
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 13

Brief Summary

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

Nutrition Aspect of Cancer; End Stage Cancer

Keywords

Palliative Phase of Cancer; Quality of life; Parenteral nutrition; Undernutrition

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• 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

• Body weight

  Time until definitive quality of life score deterioration

• Body Mass Index

  Time until definitive quality of life score deterioration

Study Arms (2)

Parenteral nutrition

EXPERIMENTAL

Parenteral nutrition will be administered to the patients

Other: Parenteral nutrition

Normal per os nutrition

NO INTERVENTION

The patients will eat orally

Interventions

Parenteral nutrition OTHER

Administration of standard intravenous nutritional products. The products are commonly used in the department where the research is conducted

Parenteral nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Institut Curie: collaborator
• Institut de Cancérologie de Lorraine: collaborator
• Centre Paul Strauss: collaborator
• Institut Jean-Godinot: collaborator
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator
• Institut Paoli-Calmettes: collaborator
• Centre Leon Berard: collaborator
• Henri Mondor University Hospital: collaborator
• Centre Oscar Lambret: collaborator
• Centre Georges Francois Leclerc: collaborator
• Centre Francois Baclesse: collaborator
• Hôpital de la Timone (MARSEILLE): collaborator

Study Sites (13)

Palliative Care Unit - CHU Jean Minjoz

Besançon, 25000, France

Location

Centre François Baclesse

Caen, 14000, France

Location

Centre hospitalier Henri Mondor

Créteil, 94010, France

Location

Centre Georges François Leclerc

Dijon, 21000, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Paoli calmettes

Marseille, 13009, France

Location

Hopital de la Timone

Marseille, France

Location

Institut Curie

Paris, 75005, France

Location

Insitut Jean Godinot

Reims, 51100, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Centre de cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (2)

• 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.

  PMID: 25248371 BACKGROUND

• 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 Jan 12;72:102905. doi: 10.1016/j.clnesp.2025.102905. Online ahead of print.

  PMID: 41534624 DERIVED

MeSH Terms

Conditions

Hyperphagia; Malnutrition

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Regis Aubry, Prof.

  Centre Hospitalier Universitaire de Besancon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: July 27, 2012
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: September 17, 2018

Record last verified: 2018-09

Locations

FR (13)