NCT07571564

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Mar 2026Sep 2027

Study Start

First participant enrolled

March 5, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 30, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

enteral nutritionadherence to enteral nutritioncompliance with enteral nutrition guidelinesmalnutritionnutritional supplementspatient education workshopstraining for healthcare staff

Outcome Measures

Primary Outcomes (1)

  • Assess compliance with recommendations for the implementation of enteral nutrition following the improvement measures implemented in Phase 2.

    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

Secondary Outcomes (10)

  • Assess the traceability of the reasons for not following a recommendation to initiate enteral nutrition in the patient's medical record

    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

    From enrollment to the end of follow-up, which is 6 months

  • Assess the delay in initiating enteral nutrition

    Since the onset of the disease at the start of enteral nutrition

  • Evaluate the implementation of recommendations based on tumor location

    From enrollment to the end of follow-up, which is 6 months

  • Identify other nutritional support methods used as alternatives to enteral nutrition.

    From enrollment to the end of follow-up, which is 6 months

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Curie

Paris, 75248, France

RECRUITING

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 6, 2026

Study Start

March 5, 2026

Primary Completion (Estimated)

September 4, 2027

Study Completion (Estimated)

September 4, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations