An observational study in Lymphoma and Myeloma, sponsored by University Hospital, Bordeaux. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-07.
Sponsored by University Hospital, Bordeaux · Observational
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 200 is above the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with lymphoma or myeloma
Exclusion Criteria:
Patients put under the protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)
Dietary Supplement: Enteral Nutrition
Protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)
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)
Time frame: From admission to recovery from aplasia (or transfer to the intensive care unit or death)
Causes of failure of enteral nutrition
All causes of primary or secondary failure that necessitated the cessation of enteral nutrition
Time frame: 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
Time frame: Every day from admission to discharge (an average of 4 weeks)
Evolution of albuminemia
Blood test carried out on admission and once a week
Time frame: 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
Time frame: 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)
Time frame: From admission to discharge (an average of 4 weeks)
Number of bacteremia and type of germs
Time frame: From admission to discharge (an average of 4 weeks)
Number of transfers to the intensive care unit
Time frame: From admission to discharge (an average of 4 weeks)
Duration of hospitalization
Number of days of hospitalization
Time frame: From admission to discharge (an average of 4 weeks)
Prokinetic and associated antiemetic treatments
Time frame: From admission to discharge (an average of 4 weeks)
Type conditioning
BEAM or Melphalan 200
Time frame: On admission, between 1 and 7 days before autologous stem cell transplantation
Plan to share: No
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux