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

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

Interventions

OTHER

Parenteral nutrition

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

Sponsors & Collaborators

• Institut Curie

  collaborator OTHER

• Institut de Cancérologie de Lorraine

  collaborator OTHER

• Centre Paul Strauss

  collaborator OTHER

• Institut Jean-Godinot

  collaborator OTHER

• Gustave Roussy, Cancer Campus, Grand Paris

  collaborator OTHER

• Institut Paoli-Calmettes

  collaborator OTHER

• Centre Leon Berard

  collaborator OTHER

• Henri Mondor University Hospital

  collaborator OTHER

• Centre Oscar Lambret

  collaborator OTHER

• Centre Georges Francois Leclerc

  collaborator OTHER

• Centre Francois Baclesse

  collaborator OTHER

• Hôpital de la Timone (MARSEILLE)

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Besancon

  lead OTHER

Principal Investigators

• Regis Aubry, Prof. · Centre Hospitalier Universitaire de Besancon

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-27

Primary Completion

2017-12-11

Completion

2017-12-11

Countries

• France

Study Locations