Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer
20 avril 2017 mis à jour par: Jaw-Yuan Wang, MD, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital
Combination of Arginine, Glutamine, and Omega-3 Fatty Acid Supplements for Perioperative Enteral Nutrition in Surgical Patients With Gastric Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)
The survey is a phase IV, prospective randomized clinical trial to determine whether an immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional status and reduce postoperative infection and surgery-induced immune suppression in patients with gastric cancer or GIST undergoing major surgery in a single medical center.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Primary Objective:
The primary end points:
To evaluate the effect of immunomodulating diets on the postoperative inflammatory response: including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α).
- Secondary Objectives:
(1). Biochemistry parameters: glucose,blood urine nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein, sodium, and leukocyte count.
(2). Nutritional status: albumin, prealbumin, BMI (3). Adverse events (4). Clinical outcomes: postoperative complications, time to first bowel action and length of hospital stay after surgery.
Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach 15 patients at least in each.
Plan of the Study:
- This is a randomized, comparative, double blinded study in 2 arms.
- Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years.
- Duration of Treatment: Treatment was administered before curative surgery for gastric adenocarcinoma or gastric GIST, and postoperative day 5-14 or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.
Type d'étude
Interventionnel
Inscription (Réel)
34
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Kaohsiung, Taïwan, 807
- Chung-Ho Memorial Hospital, Kaohsiung Medical University:
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 85 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Age between 20-85 years old
- Histologically proven primary gastric cancer or GIST.
- Patients was planning to receive elective curative gastric surgery, such as partial gastrectomy, subtotal gastrectomy, proximal gastrectomy, total gastrectomy, etc.
- Patient is able to understand the requirements of the study and written informed consent was obtained from each subject.
Exclusion Criteria:
- They were less than 20 years or over 85 years old
- Hepatic dysfunction or bile stasis (serum total bilirubin >2.5 mg/dL)
- Renal dysfunction (serum creatinine >1.5 mg/dL), or required hemodialysis
- Cardiac dysfunction (NYHA functional class >III, or stroke history)
- Severe hypoalbuminemia (albumin <2.5 g/dL)
- Karnofsky performance status less than 60
- Overweight (body mass index [BMI] >30 kg/m2)
- Exhibited drug abuse or chronic alcoholism
- Had life-threatening disease, or underwent emergent surgery
- With infection or bowel obstruction
- Pregnant or lactating
- Had received chemotherapy within 14 days of the initiation of the trial
- Had received immunosuppressive therapy or had immunological diseases recently
- Had already participated in another clinical study with an investigational drug or an investigational medical device within a month of the initiation or during the study
- Hypersensitive to casein, fish oil, soybean, or corn oil
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: immunomodulating nutrients enriched diet
Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST.
On postoperative day 3, enteral nutrition (EN) was initiated with 5% glucose in water at a rate of 20 mL/h.
On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet.
From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the interventional diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited.
|
Autres noms:
|
|
Comparateur actif: standard diet
Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the standard diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST.
On postoperative day 3, EN was initiated with 5% glucose in water at a rate of 20 mL/h.
On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the interventional diet.
From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the standard diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
immunomodulating effects
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
Inflammatory markers including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α) were employed to assess inflammatory processes.
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
blood glucose
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
blood urine nitrogen
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
blood aspartate aminotransferase (AST) in U/L
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
blood alanine aminotransferase (ALT) in U/L
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
blood triglycerides (TG) in mg/dL
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
blood cholesterol in mg/mL
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
blood low-density lipoprotein (LDL) in mg/mL
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
blood high-density lipoprotein (HDL) in mg/mL
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
blood sodium (Na) mEq/L
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
blood leukocyte count cells/μL
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
blood albumin in g/dL
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
blood prealbumin in mg/dL
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
body mass index (BMI) in kg/m^2
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
|
postoperative complications
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
postoperative complications that related to surgery
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
time to first bowel action
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
interval of surgery to first bowel action (hours)
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
|
length of hospital stay after surgery
Délai: at discharge from the hospital or 14 days after surgery, whichever occurred first
|
length of hospital stay after surgery (days)
|
at discharge from the hospital or 14 days after surgery, whichever occurred first
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chaise d'étude: Jaw-Yuan Wang, PhD, Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2011
Achèvement primaire (Réel)
1 juin 2016
Achèvement de l'étude (Réel)
1 septembre 2016
Dates d'inscription aux études
Première soumission
5 avril 2017
Première soumission répondant aux critères de contrôle qualité
20 avril 2017
Première publication (Réel)
21 avril 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 avril 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 avril 2017
Dernière vérification
1 avril 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KMUHIRB-2011-05-01(II)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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 Cancer de l'estomac
-
Jessa HospitalPas encore de recrutement
-
North Dakota State UniversityNational Institutes of Health (NIH)ComplétéRoux en Y Gastric Bypass ChirurgieÉtats-Unis
-
Natalia Valadares de MoraesUniversity of Sao Paulo; Fundação de Amparo à Pesquisa do Estado de São PauloInscription sur invitationImpact de la chirurgie bariatrique sur l'étude pharmacocinétique de la simvastatine et du carvédilolObésité | Chirurgie bariatrique | Roux-en Y Gastric BypassÉtats-Unis
-
Universitaire Ziekenhuizen KU LeuvenRecrutementChirurgie bariatrique | Sleeve Gastrectomie | Obésité et surpoids | Roux-en Y Gastric BypassPays-Bas
-
AstraZenecaActif, ne recrute pasAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian CancerÉtats-Unis, France, Royaume-Uni, Corée du Sud