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Nutrition Aspect of CancerALIM-KNCT02151214

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

A study testing Parenteral nutrition in people with Nutrition Aspect of Cancer and End Stage Cancer, run by Centre Hospitalier Universitaire de Besancon at 13 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nutrition Aspect of Cancer, End Stage Cancer
What is being tested?
Parenteral nutrition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
13 sitesFrance
Study dates
27 Jul 2012to 11 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • Palliative Care Unit - CHU Jean Minjoz

    Besançon, 25000

  • Centre François Baclesse

    Caen, 14000

  • Centre hospitalier Henri Mondor

    Créteil, 94010

  • Centre Georges François Leclerc

    Dijon, 21000

  • Centre Oscar Lambret

    Lille, 59000

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Paoli calmettes

    Marseille, 13009

  • Hopital de la Timone

    Marseille

  • Institut Curie

    Paris, 75005

  • Insitut Jean Godinot

    Reims, 51100

  • Centre Paul Strauss

    Strasbourg, 67065

  • Centre de cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54500

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

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.

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.

Read more

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 .

Being tested
Parenteral nutrition
Keywords
Palliative Phase of Cancer, Quality of life, Parenteral nutrition, Undernutrition
Medical subject headings
Hyperphagia, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parenteral nutritionOther

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

Study groups in NCT02151214
Study groupRoleWhat they receive
Parenteral nutritionExperimentalParenteral nutrition will be administered to the patients
Receives: Other: Parenteral nutrition
Normal per os nutritionNo interventionThe patients will eat orally

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Time until definitive quality of life score deterioration

Secondary outcomes (5)

  1. 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.

    Measured: Time until definitive quality of life score deterioration

  2. Overall survival

    Comparison of overall survival between the 2 groups

    Measured: Time from randomization to death

  3. 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.

    Measured: Time until definitive quality of life score deterioration

  4. Body weight

    Body weight will be compared between the 2 groups .

    Measured: Time until definitive quality of life score deterioration

  5. Body Mass Index

    Body Mass Index will be compared between the 2 groups .

    Measured: Time until definitive quality of life score deterioration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2014 (estimated)
  2. Study start27 Jul 2012
  3. Primary completion11 Dec 2017
  4. Study completion11 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02151214
Sponsor's protocol ID
ALIM-K
Acronym
ALIM-K
Status last verified
Sep 2018
First submitted
27 May 2014
Last updated
17 Sep 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25248371

  • Bouleuc C, Garabige V, Grodard G, Anota A, Aubry R, Marchal T. Impact of parenteral nutrition on oral intake and eating pleasure in advanced cancer patients: A sub-analysis of a multicenter randomized controlled trial. Clin Nutr ESPEN. 2026 Apr;72:102905. doi: 10.1016/j.clnesp.2025.102905. Epub 2026 Jan 12.

    PubMed 41534624

Questions about this trial

What is this clinical trial studying?

A study testing Parenteral nutrition in people with Nutrition Aspect of Cancer and End Stage Cancer, run by Centre Hospitalier Universitaire de Besancon at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QLQ-C15-Pal to assess Quality of Life through the physical functioning, Global Health Status and fatigue subscales (time frame: Time until definitive quality of life score deterioration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02151214, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.

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