Improvement of Nutritional Status in Cancer Patients and... | NCT07018687

Studies
Improvement of Nutritional Status in Cancer Patients and Reduction of Malnutrition

NCT07018687

Sponsor

Médipôle Lyon-Villeurbanne

Status

Active, not recruiting

Last Update Posted

Jun 12, 2025Actual

Enrollment

306Actual

Phase

Not Applicable

Conditions

Cancer

Interventions

day hospital
dietician consultation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2021Actual

Primary Completion Date

Apr 8, 2025Actual

Completion Date

Apr 8, 2026Estimated

First Submitted Date

Jun 4, 2025

First Submission Date that Met QC Criteria

Jun 4, 2025

First Posted Date

Jun 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2025

Last Update Posted Date

Jun 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The European Society for Clinical Nutrition and Metabolism (ESPEN) recommends assessing the nutritional status of each oncology patient early and in a multidisciplinary manner.

This assessment should take into account physical activity and should allow for the patient to be provided with nutritional goals adapted to their new needs. These recommendations aim to combat malnutrition, which sometimes leads to treatment suspension and thus a loss of opportunity for the patient.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

306Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Dietician consultation	Other: dietician consultation
day hospital	Experimental	mutlidisciplinary care	Other: day hospital

Interventions

Name	Type	Description	Arm Group Labels	Other Names
day hospital	Other	This multidisciplinary day hospital consists of 3 information workshops focused on balanced nutrition, oral nutritional supplements and enrichments as well as artificial feeding. During this day hospital, patients will meet with an endocrinologist nutritionist, a dietitian, and a teacher in adapted physical activity.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight loss		1 year

Secondary Outcomes

Measure	Description	Time Frame
quality of life sf-36	sf-36	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

newly diagnosed cancer

Exclusion Criteria:

other cancer previously diagnosed
under 18 years old
pregnant and breastfeeding women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Médipôle Hôpital Mutualiste		Villeurbanne		69100	France

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010359	Patient Readmission

Ancestor Terms

ID	Term
D006760	Hospitalization
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided