Clinical trial NCT02151214: Efficacy of Parenteral Nutrition in Patients at the Palliative Phase of Cancer.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Aspect of Cancer
End Stage Cancer
Keywords: Palliative Phase of Cancer
Quality of life
Parenteral nutrition
Undernutrition
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Institut Curie
name: Institut de Cancérologie de Lorraine
name: Centre Paul Strauss
name: Institut Jean-Godinot
name: Gustave Roussy, Cancer Campus, Grand Paris
name: Institut Paoli-Calmettes
name: Centre Leon Berard
name: Henri Mondor University Hospital
name: Centre Oscar Lambret
name: Centre Georges Francois Leclerc
name: Centre Francois Baclesse
name: Hôpital de la Timone (MARSEILLE)
First posted: 2014-05-30
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 .


Eligibility 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

Primary outcomes:
measure: QLQ-C15-Pal to assess Quality of Life through the physical functioning, Global Health Status and fatigue subscales
timeFrame: Time until definitive quality of life score deterioration
Secondary outcomes:
measure: QUAL-E Measuring Quality of Life at the end of Life
timeFrame: Time until definitive quality of life score deterioration
measure: Overall survival
timeFrame: Time from randomization to death
measure: Other (non-primary-end point) domains of the QLQ-C15-PAL questionnaire (pain, emotional function, nausea/vomiting, appetite, dyspnea, constipation, and sleep)
timeFrame: Time until definitive quality of life score deterioration
measure: Body weight
timeFrame: Time until definitive quality of life score deterioration
measure: Body Mass Index
timeFrame: Time until definitive quality of life score deterioration
Other outcomes:
Locations:
city: Besancon
country: France
facility: Palliative Care Unit - CHU Jean Minjoz
city: Caen
country: France
facility: Centre François Baclesse
city: Creteil
country: France
facility: Centre hospitalier Henri Mondor
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli calmettes
city: Marseille
country: France
facility: Hopital de la Timone
city: Paris
country: France
facility: Institut Curie
city: Reims
country: France
facility: Insitut Jean Godinot
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Vandoeuvre-lès-nancy
country: France
facility: Centre de cancérologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Regis Aubry, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.