Informations générales (source: ClinicalTrials.gov)
(NEPHA)
Interventional
Phase 3
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
novembre 2013
juillet 2017
29 juin 2024
Myeloablative allogeneic hematopoetic stem cell transplantation (AHSCT) are prone to
frequent secondary malnutrition to metabolic and digestive troubles due to conditioning
regimen, treatments (antibiotics, immunosuppressive therapy...) and graft complications
(graft versus host disease). In the absence of appropriate nutritional support,
myeloablative conditioning lead to a rapid serious denutrition. But, it is known as
negative independent prognostic factor of overall survival of patients who presented
malignant hemopathy treated by high-dose chemotherapy or AHSCT. Furthermore, it increases
hospitalisation delay and decreases quality of life. In AHSCT with myeloablative
conditioning, introduction of nutritional support is recommended. However, type of
nutritional support remains not clearly defined. Parenteral nutrition is user but favour
infections and secondary effects potentially decrease by intravenous glutamine. Few
previous studies with low number of patients, mainly retrospective or combining allo-and
auto HSCT had shown feasibility, acceptable tolerance and low cost of enteral nutrition
(EN). A recent prospective no-randomized study in 45 adults patients who had undergone
AHSCT with myeloablative conditioning find a significant decrease of day-100 mortality
(5% vs 30%), of infection mortality, of median duration of parenteral nutrition (PN) and
prevalence of GvH (Graft versus Host Disease) grade III-IV in EN (enteral nutrition)
group. These results had to be confirmed by a randomized study. As EN is 4 to 5 more
cheaply than PN, besides mortality/morbidity stakes for the patient, this study could
have potential economic interest.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Bruno RAYNARD | 14/06/2023 12:32:38 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age between 18 and 65 years
- Men and women
- Patients undergoing myeloablative allo-SCT
- Allo-SCT genoidentical or phenoidentical 10/10
- Patients affiliated with a social security organisation
- Patients having signed the informed consent
- Age between 18 and 65 years
- Men and women
- Patients undergoing myeloablative allo-SCT
- Allo-SCT genoidentical or phenoidentical 10/10
- Patients affiliated with a social security organisation
- Patients having signed the informed consent
- Status of tumour progression at the moment of the allo-SCT
- Artificial nutrition begun before the inclusion
- Inability to understand the protocol (linguistic barrier, cognitive difficulties)
- Contraindication or associated pathology that does not allow to carry out EN or PN
according to the protocol
- Medical history of progressive psychiatric illness
- Medical history of another progressive cancer or occurrence in the 5 previous years
- Presence of a simultaneous serious and uncontrolled disease such as severe cardiac,
renal, hepatic or respiratory failure or severe sepsis
- Previous allo-SCT
- Participation in another clinical trial studying an allograft procedure, and
applying modalities that are not available in routine practice (including innovative
immunosuppression and graft or conditioning regimens not considered as
myeloablative)