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Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology

NCT ID: NCT04703985

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-20

Study Completion Date

2023-11-06

Brief Summary

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When the digestive tract is functional, learned societies recommend the use of a nutritional support by enteral feeding. Indeed, it has many advantages (maintenance of gut trophicity, reduction of the risk of infection by reducing the incidence of bacterial translocations,...). It has been used for about fifteen years in hematology departments and offers promising results in the context of allogeneic transplantation with prospective trials in progress (NEPHA study). However, its tolerance has not been studied during autologous transplantation. This study aims to assess the success of enteral nutrition in this setting.

Detailed Description

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In the literature, there are many studies on the nutritional support to be used during allografts, that highlight the superiority of enteral nutrition over parenteral nutrition in terms of reducing co-morbidities.

Enteral nutrition is the nutritional support recommended by learned societies for therapeutic intensification with autograft of autologous hematopoietic cells in hematology. Nevertheless, enteral nutrition presents difficulties in its implementation and failures (refusal of patients, probes vomiting, neutropenic colitis, etc.), requiring the use of parenteral nutrition in case of failure.

In this context, the study proposes to assess the success and effectiveness of enteral nutrition.

Conditions

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Lymphoma Myeloma

Keywords

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Autologous stem cell transplantation Enteral feeding Myeloma Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients under the protocol of Enteral Nutrition

Patients put under the protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)

Enteral Nutrition

Intervention Type DIETARY_SUPPLEMENT

Protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)

Interventions

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Enteral Nutrition

Protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patient with lymphoma or myeloma
* Patient admitted for therapeutic intensification with autologous hematopoietic cells who are eligible for nutritional support by enteral nutrition
* Free, informed and written consent signed by the patient

Exclusion Criteria

* Refusal of the enteral nutrition
* All patients with absolute or enteral nutrition contraindications:
* Digestive fistula
* Intestinal obstruction
* Intestinal ischemia
* Active digestive bleeding
* Digestive malabsorption (short hail syndrome, bariatric surgery, gastrectomy)
* Trauma to the base of the skull or significant deviation of the nasal septum not allowing the insertion of an naso gastric probe.
* Esophagitis or barrett's esophagus
* Persistent gastro-duodenal dysfunction (gastroparesis)
* Patients admitted for autograft for the treatment of conditions other than lymphoma or myeloma (e. g. solid tumours or leukaemia)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien DAVID

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CH de la Côte Basque

Bayonne, , France

Site Status

CHU Bordeaux

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2019/29

Identifier Type: -

Identifier Source: org_study_id