Efficacy of Parenteral Nutrition in Patients at the Palliative Phase of Cancer. (ALIM-K)

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.

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 Overview

• Status: Completed
• Conditions: Nutrition Aspect of Cancer; End Stage Cancer
• Intervention / Treatment: Other: Parenteral nutrition

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besancon, France, 25000
    • Palliative Care Unit - CHU Jean Minjoz
  • Caen, France, 14000
    • Centre François Baclesse
  • Creteil, France, 94010
    • Centre Hospitalier Henri Mondor
  • Dijon, France, 21000
    • Centre Georges Francois Leclerc
  • Lille, France, 59000
    • Centre Oscar Lambret
  • Lyon, France, 69008
    • Centre Léon Bérard
  • Marseille, France
    • Hôpital de la Timone
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Paris, France, 75005
    • Institut Curie
  • Reims, France, 51100
    • Insitut Jean Godinot
  • Strasbourg, France, 67065
    • Centre Paul Strauss
  • Vandoeuvre-lès-nancy, France, 54500
    • Centre de cancérologie de Lorraine
  • Villejuif, France, 94805
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Parenteral nutrition; Parenteral nutrition will be administered to the patients	Other: Parenteral nutrition; Administration of standard intravenous nutritional products. The products are commonly used in the department where the research is conducted
NO_INTERVENTION: Normal per os nutrition; The patients will eat orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: Centre Leon Berard; Institut Paoli-Calmettes; Centre Oscar Lambret; Institut de Cancérologie de Lorraine; Gustave Roussy, Cancer Campus, Grand Paris; Institut Curie; Henri Mondor University Hospital; Centre Francois Baclesse; Centre Georges Francois Leclerc; Institut Jean-Godinot; Centre Paul Strauss; Hôpital de la Timone (MARSEILLE)
• Investigators: Principal Investigator: Regis Aubry, Prof., Centre Hospitalier Universitaire de Besançon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 27, 2012
• Primary Completion (ACTUAL): December 11, 2017
• Study Completion (ACTUAL): December 11, 2017

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (ESTIMATE): May 30, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Quality of life; Parenteral nutrition; Undernutrition; Palliative Phase of Cancer
• Other Study ID Numbers: ALIM-K