Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04703985
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Lymphoma Myeloma Dietary Supplement: Enteral Nutrition

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology
Actual Study Start Date : May 20, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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
Protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with lymphoma or myeloma
Criteria

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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04703985


Contacts
Layout table for location contacts
Contact: Sébastien DAVID +33 (0)5 24 54 91 02 david.sebastien@chu-bordeaux.fr
Contact: François-Xavier GROS francois-xavier.gros@chu-bordeaux.fr

Locations
Layout table for location information
France
CH de la Côte Basque Not yet recruiting
Bayonne, France
Contact: Fabien PIQUEMAL       fpiquemal@ch-cotebasque.fr   
Contact: Anne BANOS       abanos@ch-cotebasque.fr   
CHU Bordeaux Recruiting
Bordeaux, France
Contact: Sébastien DAVID       sebastien.david@chu-bordeaux.fr   
Contact: François-Xavier GROS       francois-xavier.gros@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Layout table for investigator information
Principal Investigator: Sébastien DAVID University Hospital, Bordeaux
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04703985    
Other Study ID Numbers: CHUBX 2019/29
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Autologous stem cell transplantation
Enteral feeding
Myeloma
Lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases