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NCT Number: NCT04703985

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

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH de la Côte Basque, Bayonne, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Enteral Nutrition

Dietary Supplement

Protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)

Primary outcomes

  1. Success rate of enteral feeding

    Time frame: From admission to recovery from aplasia (or transfer to the intensive care unit or death)

    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)

Secondary outcomes

  1. Causes of failure of enteral nutrition

    Time frame: From admission to recovery from aplasia (an average of 3 weeks)

    All causes of primary or secondary failure that necessitated the cessation of enteral nutrition

  2. Evolution of total energy intake

    Time frame: Every day from admission to discharge (an average of 4 weeks)

    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

  3. Evolution of albuminemia

    Time frame: Once a week from admission to discharge (an average of 4 weeks)

    Blood test carried out on admission and once a week

  4. Weight evolution

    Time frame: From admission to discharge (an average of 4 weeks)

    Weighing carried out on admission and on discharge. Will be used to calculate the percentage of weight loss and assess nutritional status

  5. Evolution of muscular strength

    Time frame: From admission to discharge (an average of 4 weeks)

    Measurements performed at admission and at discharge of the patient. Muscular strength is measured using a dynamometer (in kg)

  6. Number of bacteremia and type of germs

    Time frame: From admission to discharge (an average of 4 weeks)

  7. Number of transfers to the intensive care unit

    Time frame: From admission to discharge (an average of 4 weeks)

  8. Duration of hospitalization

    Time frame: From admission to discharge (an average of 4 weeks)

    Number of days of hospitalization

  9. Prokinetic and associated antiemetic treatments

    Time frame: From admission to discharge (an average of 4 weeks)

  10. Type conditioning

    Time frame: On admission, between 1 and 7 days before autologous stem cell transplantation

    BEAM or Melphalan 200

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: GAGNE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2021
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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