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

Not Applicable

Completed

• Conditions: Nutrition Aspect of Cancer; End Stage Cancer
• Interventions: Other: Parenteral nutrition

• Registration Number: NCT02151214
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-27
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-05-30
• Primary Completion: 2017-12-11
• Study Completion: 2017-12-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-14
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parenteral nutrition	Parenteral nutrition	Parenteral nutrition will be administered to the patients

Primary Outcome Measures

Name	Time	Method
QLQ-C15-Pal to assess Quality of Life through the physical functioning, Global Health Status and fatigue subscales	Time until definitive quality of life score deterioration	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.

Secondary Outcome Measures

Name	Time	Method
QUAL-E Measuring Quality of Life at the end of Life	Time until definitive quality of life score deterioration	Questionaire for patients who believe they are nearing the end of life and comparison between the 2 groups.
Overall survival	Time from randomization to death	Comparison of overall survival between the 2 groups
Body weight	Time until definitive quality of life score deterioration	Body weight will be compared between the 2 groups .
Body Mass Index	Time until definitive quality of life score deterioration	Body Mass Index will be compared between the 2 groups .
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	Comparison of other domains of the QLQ-C15-PAL questionnaire between the 2 groups.

Trial Locations

Locations (13)

Palliative Care Unit - CHU Jean Minjoz; 🇫🇷 Besancon, France

Centre hospitalier Henri Mondor; 🇫🇷 Creteil, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut Paoli calmettes; 🇫🇷 Marseille, France

Hopital de la Timone; 🇫🇷 Marseille, France

Institut Curie; 🇫🇷 Paris, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Insitut Jean Godinot; 🇫🇷 Reims, France

Centre de cancérologie de Lorraine; 🇫🇷 Vandoeuvre-lès-nancy, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France