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Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer

20. April 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Primary Objective:

  1. 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).

  2. 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:

  1. This is a randomized, comparative, double blinded study in 2 arms.
  2. 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.
  3. 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or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

34

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Nahrungsergänzungsmittel: immunomodulating nutrients enriched diet
Andere Namen:
  • neo-mune
Aktiver Komparator: 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.
Nahrungsergänzungsmittel: standard diet

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
immunomodulating effects
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
blood glucose
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Ermittler

  • Studienstuhl: Jaw-Yuan Wang, PhD, Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juni 2011

Primärer Abschluss (Tatsächlich)

1. Juni 2016

Studienabschluss (Tatsächlich)

1. September 2016

Studienanmeldedaten

Zuerst eingereicht

5. April 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. April 2017

Zuerst gepostet (Tatsächlich)

21. April 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. April 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. April 2017

Zuletzt verifiziert

1. April 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KMUHIRB-2011-05-01(II)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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