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

Lymphoma Clinical Trial

— GAGNE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703985
• Other study ID #: CHUBX 2019/29
• Status: Completed
• Start date: May 20, 2021
• Est. completion date: November 6, 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 6, 2023
• Est. primary completion date: November 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lymphoma
• Myeloma

Intervention

Dietary Supplement:
• Enteral Nutrition
Protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)

Locations

Country	Name	City	State
France	CH de la Côte Basque	Bayonne
France	CHU Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Number of bacteremia and type of germs		From admission to discharge (an average of 4 weeks)
Secondary	Number of transfers to the intensive care unit		From admission to discharge (an average of 4 weeks)
Secondary	Duration of hospitalization	Number of days of hospitalization	From admission to discharge (an average of 4 weeks)
Secondary	Prokinetic and associated antiemetic treatments		From admission to discharge (an average of 4 weeks)
Secondary	Type conditioning	BEAM or Melphalan 200	On admission, between 1 and 7 days before autologous stem cell transplantation