Clinical trial NCT04703985: Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology
Official title: Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Myeloma
Keywords: Autologous stem cell transplantation
Enteral feeding
Myeloma
Lymphoma
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lymphoma or myeloma

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Success rate of enteral feeding
timeFrame: From admission to recovery from aplasia (or transfer to the intensive care unit or death)
Secondary outcomes:
measure: Causes of failure of enteral nutrition
timeFrame: From admission to recovery from aplasia (an average of 3 weeks)
measure: Evolution of total energy intake
timeFrame: Every day from admission to discharge (an average of 4 weeks)
measure: Evolution of albuminemia
timeFrame: Once a week from admission to discharge (an average of 4 weeks)
measure: Weight evolution
timeFrame: From admission to discharge (an average of 4 weeks)
measure: Evolution of muscular strength
timeFrame: From admission to discharge (an average of 4 weeks)
measure: Number of bacteremia and type of germs
timeFrame: From admission to discharge (an average of 4 weeks)
measure: Number of transfers to the intensive care unit
timeFrame: From admission to discharge (an average of 4 weeks)
measure: Duration of hospitalization
timeFrame: From admission to discharge (an average of 4 weeks)
measure: Prokinetic and associated antiemetic treatments
timeFrame: From admission to discharge (an average of 4 weeks)
measure: Type conditioning
timeFrame: On admission, between 1 and 7 days before autologous stem cell transplantation
Other outcomes:
Locations:
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Sébastien DAVID
role: PRINCIPAL_INVESTIGATOR
References: