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

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

End Stage Cancer

Nutrition Aspect of Cancer

Treatments

Other: Parenteral nutrition

Study type

Interventional

Funder types

Other

Identifiers

NCT02151214

ALIM-K

Details and patient eligibility

About

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 .

Enrollment

106 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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