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

Nutrition Aspect of Cancer Clinical Trial

— ALIM-K  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151214
• Other study ID #: ALIM-K
• Status: Completed
• Phase: N/A
• Start date: July 27, 2012
• Est. completion date: December 11, 2017

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 11, 2017
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Cancer
• Nutrition Aspect of Cancer

Intervention

Other:
• Parenteral nutrition
Administration of standard intravenous nutritional products. The products are commonly used in the department where the research is conducted

Locations

Country	Name	City	State
France	Palliative Care Unit - CHU Jean Minjoz	Besancon
France	Centre François Baclesse	Caen
France	Centre hospitalier Henri Mondor	Creteil
France	Centre Georges François Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	Hopital de la Timone	Marseille
France	Institut Paoli calmettes	Marseille
France	Institut Curie	Paris
France	Insitut Jean Godinot	Reims
France	Centre Paul Strauss	Strasbourg
France	Centre de cancérologie de Lorraine	Vandoeuvre-lès-nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (13)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Centre Francois Baclesse, Centre Georges Francois Leclerc, Centre Leon Berard, Centre Oscar Lambret, Centre Paul Strauss, Gustave Roussy, Cancer Campus, Grand Paris, Henri Mondor University Hospital, Hôpital de la Timone (MARSEILLE), Institut Curie, Institut de Cancérologie de Lorraine, Institut Jean-Godinot, Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QLQ-C15-Pal to assess Quality of Life through the physical functioning, Global Health Status and fatigue subscales	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.	Time until definitive quality of life score deterioration
Secondary	QUAL-E Measuring Quality of Life at the end of Life	Questionaire for patients who believe they are nearing the end of life and comparison between the 2 groups.	Time until definitive quality of life score deterioration
Secondary	Overall survival	Comparison of overall survival between the 2 groups	Time from randomization to death
Secondary	Other (non-primary-end point) domains of the QLQ-C15-PAL questionnaire (pain, emotional function, nausea/vomiting, appetite, dyspnea, constipation, and sleep)	Comparison of other domains of the QLQ-C15-PAL questionnaire between the 2 groups.	Time until definitive quality of life score deterioration
Secondary	Body weight	Body weight will be compared between the 2 groups .	Time until definitive quality of life score deterioration
Secondary	Body Mass Index	Body Mass Index will be compared between the 2 groups .	Time until definitive quality of life score deterioration