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NCT Number: NCT02151214

Efficacy of Parenteral Nutrition in Patients at 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.

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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Key information

Conditions

Nutrition Aspect of Cancer End Stage Cancer Hyperphagia Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palliative Care Unit - CHU Jean Minjoz, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parenteral nutrition

Other

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

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. QUAL-E Measuring Quality of Life at the end of Life

    Time frame: Time until definitive quality of life score deterioration

    Questionaire for patients who believe they are nearing the end of life and comparison between the 2 groups.

  2. Overall survival

    Time frame: Time from randomization to death

    Comparison of overall survival between the 2 groups

  3. Other (non-primary-end point) domains of the QLQ-C15-PAL questionnaire (pain, emotional function, nausea/vomiting, appetite, dyspnea, constipation, and sleep)

    Time frame: Time until definitive quality of life score deterioration

    Comparison of other domains of the QLQ-C15-PAL questionnaire between the 2 groups.

  4. Body weight

    Time frame: Time until definitive quality of life score deterioration

    Body weight will be compared between the 2 groups .

  5. Body Mass Index

    Time frame: Time until definitive quality of life score deterioration

    Body Mass Index will be compared between the 2 groups .

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • 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 Jean-Godinot
  • Institut Paoli-Calmettes
  • Institut de Cancérologie de Lorraine

Registry information

Official study 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.

Acronym: ALIM-K

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
May 30, 2014
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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