NCT04703985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2023

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

2.5 years

First QC Date

December 22, 2020

Last Update Submit

December 6, 2023

Conditions

LymphomaMyeloma

Keywords

Autologous stem cell transplantationEnteral feedingMyelomaLymphoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Causes of failure of enteral nutrition

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

  • Evolution of total energy intake

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

  • Evolution of albuminemia

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

  • Weight evolution

    From admission to discharge (an average of 4 weeks)

  • Evolution of muscular strength

    From admission to discharge (an average of 4 weeks)

  • +5 more secondary outcomes

Study Arms (1)

Patients under the protocol of Enteral Nutrition

Patients put under the protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)

Dietary Supplement: Enteral Nutrition

Interventions

Enteral NutritionDIETARY_SUPPLEMENT

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

Patients under the protocol of Enteral Nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lymphoma or myeloma

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CH de la Côte Basque

Bayonne, France

Location

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

LymphomaNeoplasms, Plasma Cell

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Sébastien DAVID

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

January 11, 2021

Study Start

May 20, 2021

Primary Completion

November 6, 2023

Study Completion

November 6, 2023

Last Updated

December 7, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)