Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer
20. dubna 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.
Typ studie
Intervenční
Zápis (Aktuální)
34
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Kaohsiung, Tchaj-wan, 807
- Chung-Ho Memorial Hospital, Kaohsiung Medical University:
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
20 let až 85 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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Ostatní jména:
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Aktivní komparátor: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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immunomodulating effects
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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Inflammatory markers including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α) were employed to assess inflammatory processes.
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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blood glucose
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood urine nitrogen
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood aspartate aminotransferase (AST) in U/L
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood alanine aminotransferase (ALT) in U/L
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood triglycerides (TG) in mg/dL
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood cholesterol in mg/mL
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood low-density lipoprotein (LDL) in mg/mL
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood high-density lipoprotein (HDL) in mg/mL
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood sodium (Na) mEq/L
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood leukocyte count cells/μL
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood albumin in g/dL
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood prealbumin in mg/dL
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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body mass index (BMI) in kg/m^2
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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postoperative complications
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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postoperative complications that related to surgery
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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time to first bowel action
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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interval of surgery to first bowel action (hours)
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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length of hospital stay after surgery
Časové okno: at discharge from the hospital or 14 days after surgery, whichever occurred first
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length of hospital stay after surgery (days)
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Studijní židle: Jaw-Yuan Wang, PhD, Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. června 2011
Primární dokončení (Aktuální)
1. června 2016
Dokončení studie (Aktuální)
1. září 2016
Termíny zápisu do studia
První předloženo
5. dubna 2017
První předloženo, které splnilo kritéria kontroly kvality
20. dubna 2017
První zveřejněno (Aktuální)
21. dubna 2017
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
21. dubna 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. dubna 2017
Naposledy ověřeno
1. dubna 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- KMUHIRB-2011-05-01(II)
Plán pro data jednotlivých účastníků (IPD)
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produkt vyrobený a vyvážený z USA
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