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

Study Overview
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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.

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

Conditions
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Myeloma, Lymphoma

Intervention / Treatment
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* Dietary Supplement: Enteral Nutrition


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients under the protocol of Enteral Nutrition<br>Patients put under the protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200) | Dietary Supplement: Enteral Nutrition<br>* Protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of enteral feeding | Enteral Nutrition will be considered as a success if : TEI / ER > 70%. On average until recovery from aplasia (or transfer to the intensive care unit or death). TEI : Total Energy Intake (per-os + enteral nutrition + glucose solutions) ER : Energy Requirement (assessed patient needs) | From admission to recovery from aplasia (or transfer to the intensive care unit or death) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causes of failure of enteral nutrition | All causes of primary or secondary failure that necessitated the cessation of enteral nutrition | From admission to recovery from aplasia (an average of 3 weeks) | 
| Evolution of total energy intake | All sources of energy intake (per-os, enteral nutrition, parenteral nutrition, glucose solutions) These will be compared to the estimated needs of patients and expressed as a % of coverage of these needs | Every day from admission to discharge (an average of 4 weeks) | 
| Evolution of albuminemia | Blood test carried out on admission and once a week | Once a week from admission to discharge (an average of 4 weeks) | 
| Weight evolution | Weighing carried out on admission and on discharge. Will be used to calculate the percentage of weight loss and assess nutritional status | From admission to discharge (an average of 4 weeks) | 
| Evolution of muscular strength | Measurements performed at admission and at discharge of the patient. Muscular strength is measured using a dynamometer (in kg) | From admission to discharge (an average of 4 weeks) | 
| Number of bacteremia and type of germs |  | From admission to discharge (an average of 4 weeks) | 
| Number of transfers to the intensive care unit |  | From admission to discharge (an average of 4 weeks) | 
| Duration of hospitalization | Number of days of hospitalization | From admission to discharge (an average of 4 weeks) | 
| Prokinetic and associated antiemetic treatments |  | From admission to discharge (an average of 4 weeks) | 
| Type conditioning | BEAM or Melphalan 200 | On admission, between 1 and 7 days before autologous stem cell transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous stem cell transplantation, Enteral feeding, Myeloma, Lymphoma