- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02880709
The Effect of Special Diets in Hematological Cancer Patients
The Effect of Special Diets on Weight and Nutritional Intake in Haematological Cancer Patients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study was approved by the regional scientific ethical committee, and was registered in ClinicalTrial.gov NTC no………...
Patients were selected consecutively with acute and chronic leukemia and lymphoma, Hodg-kin's lymphoma, and Non-Hodgkin's lymphoma in treatment with chemotherapy.
Eligible patients were aged >18 years, and only patients who were able to com-municate and understand written and oral information and receive food orally were included. The special diets were developed at the Central Kitchen at Rigshospitalet Initially, two single blinded pilot studies of five patients were performed, with the same inclusion and exclusion criteria as the main study. In the first study patients tested 17 dishes with a taste-mix of dominating umami, a little sweet, sour and salt, and no bitter. In the second round six dishes were selected based on the results from the first round. All dishes had a high energy-density, with a protein content of at least 5 g/100 g. Every dish was tested both before and after chemotherapy. Patients rated acceptability on 9-point scales.
The clinical controlled cross-over design with two periods of four weeks, intervention and control, tested four dishes selected after the second pilot study. 32 patients were included in that trial, and they started with their habitual diet as control and then switched to recommendation of introduction of the four dishes selected.
The patients registered their weight every time they were at the hospital. During the intervention period the patients received a recipe booklet with the four dishes and a noted every time they ingested one of these. Compliance measurements were based on this registration. Patients had access to the dishes when in-patients, but they did their own cooking at home. It was possible to buy the similar dishes as pre-prepared meals in the supermarkets. The dishes in the final study were: Chili con Carne, Chicken in Curry, Curry Soup and Pasta Carbonara with added curry.
Data were analyzed with R (version 2.15.3). In histograms used to show the degree of acceptability for the dishes in the pilot studies, answers above 5 were graded as high grade of acceptance. To present descriptive statistics, the results were expressed as mean ± standard deviation (SD), median (interquartile range (IQR)) and range. As the data did not show a normal distribution, Wilcoxon rang-sum tests (paired and unpaired) were used. Analyses were carried out both according to intention-to- treat (ITT) and per-protocol (PP) principles. As many of the data sampled, especially the subjective ones, sensitivity analysis (± 10% correction of the results) were performed.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
-
Copenhagen, Danemark, 2100
- Hematological clinic
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Hematological cancer
- Ongoing chemotherapy
- Ability to eat by mouth
- Informed consent
Exclusion Criteria:
- Lack of the ability to understand the informations given
- Lack of the ability to understand the conditions of the experiment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Special diet
Special diet with taste, energy-and protein content adjusted according to previous finding
|
Tate and energy content adjusted with spices to obtain maximal intake
|
Aucune intervention: Usual diet
Patients habitual diet
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Weight loss
Délai: 30 days
|
30 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jens Rikardt Andersen, MD,MPA, University of Copenhagen
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Curry
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Special diet
-
University of Alabama at BirminghamNational Multiple Sclerosis SocietyComplétéSclérose en plaquesÉtats-Unis
-
Mondelēz International, Inc.KGK Science Inc.Complété
-
Icahn School of Medicine at Mount SinaiUniversity of Massachusetts, Worcester; The Leona M. and Harry B. Helmsley...Actif, ne recrute pasGrossesse | Maladie de CrohnÉtats-Unis
-
Utah State UniversityGreenAcres FoundationRecrutementRéaction inflammatoireÉtats-Unis
-
University of TorontoRecrutementMaladies cardiovasculairesCanada
-
International Centre for Diarrhoeal Disease Research...RecrutementEnfants mal nourrisBengladesh
-
Hospital de Clinicas de Porto AlegreRésiliéPression artérielleBrésil
-
Tel Aviv UniversityComplété
-
Mondelēz International, Inc.KGK Science Inc.Complété
-
University of PittsburghComplétéMaladies cardiovasculaires | ObésitéÉtats-Unis