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

University Hospital of Bordeaux

Status: Completed

Conditions: Lymphoma; Myeloma

Treatments: Dietary Supplement: Enteral Nutrition

Study type: Observational

Funder types: Other

Identifiers

NCT04703985

CHUBX 2019/29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

200 participants in 1 patient group

Patients under the protocol of Enteral Nutrition

Description:

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

Treatment:

Dietary Supplement: Enteral Nutrition