NCT04703985Completed
Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology
Source: ClinicalTrials.gov · Last updated 7 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 22 Dec 2020
- Start date
- 20 May 2021
- Primary completion date
- 6 Nov 2023
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Multiple myeloma
- NCT number
- NCT04703985
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 20 May 2021 to the primary completion date, 6 Nov 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Digestive fistula
- Active digestive bleeding
- Digestive malabsorption (short hail syndrome, bariatric surgery, gastrectomy)
- Patients admitted for autograft for the treatment of conditions other than lymphoma or myeloma (e. g. solid tumours or leukaemia)
Other
- Refusal of the enteral nutrition
- All patients with absolute or enteral nutrition contraindications:
- Intestinal obstruction
- Intestinal ischemia
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CH de la côte Basque Coordinator of this site? Confirm its status | Bayonne | France | Unknown status |
| CHU Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.