Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Adherence to Enteral Nutrition (ADHENUTE)

30 aprile 2026 aggiornato da: Institut Curie

Malnutrition is a major challenge in cancer nutrition, affecting approximately 40% of cancer patients and having negative consequences on treatment efficacy, quality of life, and prognosis. It must be detected and managed early, based on clinical and laboratory criteria defined by the HAS recommendations.

To address this, several nutritional strategies are available, ranging from fortified oral feeding to artificial nutrition. Enteral nutrition, which is more physiological and carries fewer risks than parenteral nutrition, is recommended as the first-line treatment. Tools such as personalized care plans and guidelines help tailor patient care.

However, enteral nutrition remains underutilized in clinical practice, despite the recommendations. The ADHENUTE study, conducted at the Institut Curie, showed low compliance with recommendations (31%) and a tendency to favor oral nutritional supplements, even in severely malnourished patients. The lack of traceability of decisions makes it difficult to identify barriers, although patient refusal is sometimes mentioned.

To improve this situation, corrective measures have been implemented:

  • for patients, through educational workshops to help them better understand and accept enteral nutrition;
  • for healthcare providers, through training sessions to address reservations and enhance knowledge.

A third phase of the study aims to evaluate the impact of these actions, with the goal of increasing adherence to recommendations and the use of enteral nutrition.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

The primary goal in cancer nutrition is to prevent, limit, and treat malnutrition. On average, 40% of cancer patients are malnourished (with this prevalence rising to as high as 90% depending on the cancer's location and the stage of the disease). Studies have shown that malnutrition reduces the effectiveness of cancer treatments, patients' quality of life, and their prognosis for recovery.

Screening for and management of malnutrition must be initiated early and based on the recommendations of the French National Authority for Health (HAS) in its guidelines titled "Diagnosis of Malnutrition in Children and Adults," updated in November 2020 and November 2021. In adults, the diagnosis of malnutrition (and its severity) is based on phenotypic and etiological criteria, including weight loss, Body Mass Index (BMI), albumin levels, and muscle strength measurements.

Dietary measures and interventions-ranging from optimizing oral intake to the use of Oral Nutritional Supplements (ONS) and Artificial Nutrition (AN)-help combat malnutrition. Enteral nutrition, which utilizes the digestive system, is the more physiological and effective solution, carrying a lower risk of infection. It is the preferred first-line treatment over parenteral nutrition.

Healthcare professionals can use the HAS's Personalized Care Plans (PPS) for oncology, which propose strategies based on treatment, age, and tumor location, as well as the phase of treatment (curative, initial palliative, advanced, or terminal). The nutritional care decision tree, which establishes a management strategy based on the patient's nutritional status and the severity of malnutrition-and is not specific to oncology-is a validated tool.

Despite the recommendations, the use of enteral nutrition remains insufficient. Indeed, and more broadly, this issue of non-compliance with recommendations for the implementation of enteral nutrition is commonly observed. This is confirmed by the study conducted by Defteros et al., which demonstrated that adhering to ESPEN (European Society for Clinical Nutrition and Metabolism) recommendations in clinical practice is difficult.

At the Institut Curie, until now, there has been little data on the extent to which recommendations for initiating enteral nutrition are followed.

We designed the ADHENUTE study (ADHEsion to Enteral Nutrition) to assess adherence to an enteral nutrition program in medical oncology and compliance with recommendations for implementing this nutritional support, both before and after corrective measures were implemented.

The study is designed in three phases:

> Phase 1: Verification of the hypothesis that enteral nutrition is under-used compared to recommendations, through a retrospective analysis of 200 medical records, and identification of barriers to the implementation of this nutritional support.

This phase was completed and highlighted in an article submitted to the *Bulletin du cancer* in March 2025, titled "Underutilization of enteral nutrition in medical oncology compared to recommendations." This initial phase revealed a compliance rate of 31% with the recommendations for enteral nutrition [95% CI: 20-42]. It also provided insight into which nutritional products were most frequently prescribed. A comparison between the recommended theoretical nutritional management and the management actually implemented in practice reveals a shift away from "enteral nutrition" toward "oral nutritional supplements." Furthermore, among the 189 usable records, 45% of patients were severely malnourished. Patients who received enteral nutrition generally had a poorer nutritional status than the overall study population: 21 out of 22 patients were malnourished (15 severely). However, the more severe the malnutrition, the more resistant it becomes to treatment, rendering dietary measures ineffective [10] and increasing the risk of complications during their implementation (notably an increased risk of inappropriate refeeding syndrome).

In their 2015 article [11], Coti-Bertrand et al. recommend tracking the indication for enteral nutrition as part of their criteria for evaluating and improving practices: "The indication for enteral nutrition is specified in the medical record." In the Adhénute study, documentation did not allow for the identification of the reason for non-compliance with enteral nutrition recommendations in each case. Among the records analyzed, the patient's refusal of enteral nutrition was mentioned in 5 records. For the 50 cases where enteral nutrition was not initiated despite recommendations to do so, this lack of traceability makes it impossible to determine why enteral nutrition was not provided.

  • Step 2: Implementation of corrective measures for patients requiring enteral nutrition through an educational presentation of the project, and for healthcare providers and prescribing physicians through training sessions.

The proposal for corrective measures constitutes the second phase of the Adhénute project. These measures were implemented exclusively at the Saint Cloud site. The Paris site benefited from standard practices for improving clinical care.

They targeted two groups:

> Patients for whom enteral nutrition is indicated: The full report on best practices for dietary management in oncology regarding enteral nutrition [12] states that it is recommended to obtain the patient's consent through informed consent.

As part of Adhénute's corrective measures, enteral nutrition programs were presented to patients through educational initiatives such as Patient Therapeutic Education (PTE) workshops, with the aim of improving their understanding of this approach, reducing their level of apprehension, and increasing adherence to this nutritional method. This workshop, titled "I'm Committed to Enteral Nutrition," was designed for individual sessions or to include a caregiver and was offered to patients requiring enteral nutrition-whether in outpatient care or hospitalized-as soon as the need was identified (often on the same day, making it difficult to formalize the workshop into a full-fledged PTE program with a comprehensive pathway including BEPs). It includes 6 tools that can be adapted to the patient (material and nasogastric tube cards / keyword cards / food intake pie chart / choice method cards / arrows to associate with adverse effects / question-and-answer bubbles). The "emotions wheel" is used at the beginning and end of the workshop. An informational brochure is provided at the end of the workshop.

> Healthcare providers (doctors, nurses, nursing assistants). Training sessions were offered to medical and nursing staff.

The results of the first phase of Adhénute were presented to prescribing physicians, along with a review of the recommendations for implementing enteral nutrition during medical staff meetings in the target departments.

A training session titled "Overcoming Reluctance Toward Enteral Nutrition" was offered to medical and nursing teams in the target departments. Designed as a participatory and interactive ETP workshop, this training helped identify common barriers conveyed to patients by healthcare staff, enhance knowledge about this approach, and clarify the expected benefits for the patient.

This step has been completed

> Step 3: Evaluation of the impact of the improvement measures implemented in Step 2 To this end, a prospective analysis of patient records from those hospitalized in a medical oncology unit following the implementation of improvement measures will be conducted at the Saint-Cloud site. We expect to see an increase in the rate of compliance with recommendations as a result of these improvement measures.

Tipo di studio

Osservativo

Iscrizione (Stimato)

80

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione di probabilità

Popolazione di studio

We propose to conduct a prospective, single-center cohort study involving 80 patients. Patients will be enrolled at the Institut Curie in Saint Cloud over a 12-month period and followed for 6 months. Patients must be adults and hospitalized in a medical oncology ward.

Descrizione

Inclusion Criteria:

  • Patients hospitalized (including those in the day hospital) in a medical oncology unit;
  • Adults;
  • Men or women;
  • Patients for whom enteral nutrition is indicated according to SFNCM recommendations;

Exclusion Criteria:

  • Minors (under 18 years of age)
  • Patients receiving end-of-life palliative care
  • Individuals deprived of their liberty or under legal guardianship (including conservatorship);
  • Adults under judicial protection;
  • Inability to participate in the study for geographical, social, or psychological reasons.
  • Persons referred to in Articles L. 1121-5 through L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g., minors, adults under guardianship, etc.).
  • Patients who do not speak or understand French.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assess compliance with recommendations for the implementation of enteral nutrition following the improvement measures implemented in Phase 2.
Lasso di tempo: From enrollment to the end of follow-up, which is 6 months
Percentage of patients for whom the recommendations are followed. Compliance with the recommendations will be assessed by comparing the recommended nutritional interventions with those actually implemented.
From enrollment to the end of follow-up, which is 6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assess the traceability of the reasons for not following a recommendation to initiate enteral nutrition in the patient's medical record
Lasso di tempo: From enrollment to the end of follow-up, which is 6 months
Percentage of cases detailing the reasons for exclusion from the nutrition program
From enrollment to the end of follow-up, which is 6 months
Assess the role of the dietetics department in screening for malnutrition and in the implementation of enteral nutrition
Lasso di tempo: From enrollment to the end of follow-up, which is 6 months
Percentage of patients treated by the dietetics department
From enrollment to the end of follow-up, which is 6 months
Assess the delay in initiating enteral nutrition
Lasso di tempo: Since the onset of the disease at the start of enteral nutrition
Percentage of weight loss (since the onset of the disease) among patients at the start of enteral nutrition
Since the onset of the disease at the start of enteral nutrition
Evaluate the implementation of recommendations based on tumor location
Lasso di tempo: From enrollment to the end of follow-up, which is 6 months
Percentage of patients for whom the recommendations are followed, by cancer site
From enrollment to the end of follow-up, which is 6 months
Identify other nutritional support methods used as alternatives to enteral nutrition.
Lasso di tempo: From enrollment to the end of follow-up, which is 6 months
Percentage of patients who received: Dietary Counseling / Oral Nutritional Supplements / Parenteral Nutrition / none, instead of Enteral Nutrition.
From enrollment to the end of follow-up, which is 6 months
Assess the time required for the patient to tolerate enteral nutrition
Lasso di tempo: From enrollment to the end of follow-up, which is 6 months
Number of days between the first submission and acceptance
From enrollment to the end of follow-up, which is 6 months
Assess the duration of compliance
Lasso di tempo: From enrollment to the end of follow-up, which is 6 months
Number of days on enteral nutrition
From enrollment to the end of follow-up, which is 6 months
Describe the reasons for discontinuing enteral nutrition
Lasso di tempo: From enrollment to the end of follow-up, which is 6 months
number and reasons for withdrawals
From enrollment to the end of follow-up, which is 6 months
Assessing the resolution of malnutrition through the implementation of recommendations
Lasso di tempo: From enrollment to the end of follow-up, which is 6 months
Comparison of weight changes between patients receiving enteral nutrition and those not receiving enteral nutrition
From enrollment to the end of follow-up, which is 6 months
Assess the benefits of following the recommendations
Lasso di tempo: From enrollment to the end of follow-up, which is 6 months
Comparison of disease progression between populations with and without NE (Regression / Stability / Progression / Not evaluated)
From enrollment to the end of follow-up, which is 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 marzo 2026

Completamento primario (Stimato)

4 settembre 2027

Completamento dello studio (Stimato)

4 settembre 2027

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Nutrizione enterale

Sottoscrivi