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

Last updated: December 6, 2023
Sponsor: University Hospital, Bordeaux
Overall Status: Completed

Phase

N/A

Condition

Lymphoma

Hematologic Neoplasms

Carcinoma

Treatment

Enteral Nutrition

Clinical Study ID

NCT04703985
CHUBX 2019/29
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 notallowing 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 ormyeloma (e. g. solid tumours or leukaemia)

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Enteral Nutrition
Phase:
Study Start date:
May 20, 2021
Estimated Completion Date:
November 06, 2023

Study Description

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.

Connect with a study center

  • CH de la Côte Basque

    Bayonne,
    France

    Site Not Available

  • CHU Bordeaux

    Bordeaux,
    France

    Site Not Available

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