LymphomaGAGNENCT04703985
Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology
An observational study of Lymphoma and Myeloma, run by University Hospital, Bordeaux at 2 sites in France.
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,...). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Enteral Nutrition
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 20 May 2021to 6 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lymphoma or myeloma
Who may be able to join
- 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
Who cannot join
- Refusal of the enteral nutrition
- All patients with absolute or enteral nutrition contraindications:
- Digestive fistula
- Intestinal obstruction
- Intestinal ischemia
- Active digestive bleeding
Show all 11Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Being tested
- Enteral Nutrition
- Keywords
- Autologous stem cell transplantation, Enteral feeding, Myeloma, Lymphoma
- Medical subject headings
- Lymphoma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral NutritionDietary supplement
Protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)
| Study group | Role | What they receive |
|---|---|---|
| Patients under the protocol of Enteral Nutrition | Patients put under the protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200) Receives: Dietary Supplement: Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From admission to recovery from aplasia (or transfer to the intensive care unit or death)
Secondary outcomes (10)
Causes of failure of enteral nutrition
All causes of primary or secondary failure that necessitated the cessation of enteral nutrition
Measured: 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
Measured: Every day from admission to discharge (an average of 4 weeks)
Evolution of albuminemia
Blood test carried out on admission and once a week
Measured: 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
Measured: 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)
Measured: From admission to discharge (an average of 4 weeks)
Number of bacteremia and type of germs
Measured: From admission to discharge (an average of 4 weeks)
Number of transfers to the intensive care unit
Measured: From admission to discharge (an average of 4 weeks)
Duration of hospitalization
Number of days of hospitalization
Measured: From admission to discharge (an average of 4 weeks)
Prokinetic and associated antiemetic treatments
Measured: From admission to discharge (an average of 4 weeks)
Type conditioning
BEAM or Melphalan 200
Measured: On admission, between 1 and 7 days before autologous stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start20 May 2021
- Primary completion6 Nov 2023
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien DAVID, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703985
- Sponsor's protocol ID
- CHUBX 2019/29
- Acronym
- GAGNE
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2020
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology
- ClinicalTrials.gov ID
- NCT04703985
- Acronym / sponsor ID
- GAGNE / CHUBX 2019/29
- Keywords
- Autologous stem cell transplantation, Enteral feeding, Myeloma, Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients under the protocol of Enteral Nutrition | – | Dietary Supplement: Enteral NutritionPatients put under the protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lymphoma or myeloma
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Refusal of the enteral nutrition
- All patients with absolute or enteral nutrition contraindications:
- Digestive fistula
- Intestinal obstruction
- Intestinal ischemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral NutritionProtocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200) | Dietary supplement | Patients under the protocol of Enteral Nutrition |
Primary outcome
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)
10 secondary outcomes
Causes of failure of enteral nutrition
Time frame: From admission to recovery from aplasia (an average of 3 weeks)
Evolution of total energy intake
Time frame: Every day from admission to discharge (an average of 4 weeks)
Evolution of albuminemia
Time frame: Once a week from admission to discharge (an average of 4 weeks)
Weight evolution
Time frame: From admission to discharge (an average of 4 weeks)
Evolution of muscular strength
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
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
Time frame: On admission, between 1 and 7 days before autologous stem cell transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien DAVID principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Myeloma, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of enteral feeding (time frame: From admission to recovery from aplasia (or transfer to the intensive care unit or death)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.