Efficacy of Parenteral Nutrition in Patients at the Palliative Phase of Cancer.
NCT ID: NCT02151214
Last Updated: 2018-09-17
Study Results
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Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2012-07-27
2017-12-11
Brief Summary
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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 .
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Parenteral nutrition
Parenteral nutrition will be administered to the patients
Parenteral nutrition
Administration of standard intravenous nutritional products. The products are commonly used in the department where the research is conducted
Normal per os nutrition
The patients will eat orally
No interventions assigned to this group
Interventions
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Parenteral nutrition
Administration of standard intravenous nutritional products. The products are commonly used in the department where the research is conducted
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Institut Curie
OTHER
Institut de Cancérologie de Lorraine
OTHER
Centre Paul Strauss
OTHER
Institut Jean-Godinot
OTHER
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Institut Paoli-Calmettes
OTHER
Centre Leon Berard
OTHER
Henri Mondor University Hospital
OTHER
Centre Oscar Lambret
OTHER
Centre Georges Francois Leclerc
OTHER
Centre Francois Baclesse
OTHER
Hôpital de la Timone (MARSEILLE)
UNKNOWN
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Régis AUBRY
Pr
Principal Investigators
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Regis Aubry, Prof.
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Besancon
Locations
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Palliative Care Unit - CHU Jean Minjoz
Besançon, , France
Centre François Baclesse
Caen, , France
Centre hospitalier Henri Mondor
Créteil, , France
Centre Georges François Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli calmettes
Marseille, , France
Hopital de la Timone
Marseille, , France
Institut Curie
Paris, , France
Insitut Jean Godinot
Reims, , France
Centre Paul Strauss
Strasbourg, , France
Centre de cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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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.
Other Identifiers
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ALIM-K
Identifier Type: -
Identifier Source: org_study_id
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