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Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer

2017년 4월 20일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.

연구 유형

중재적

등록 (실제)

34

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
건강 보조 식품: immunomodulating nutrients enriched diet
다른 이름들:
  • neo-mune
활성 비교기: 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.
건강 보조 식품: standard diet

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
immunomodulating effects
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
blood glucose
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Kaohsiung Medical University Chung-Ho Memorial Hospital

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2011년 6월 1일

기본 완료 (실제)

2016년 6월 1일

연구 완료 (실제)

2016년 9월 1일

연구 등록 날짜

최초 제출

2017년 4월 5일

QC 기준을 충족하는 최초 제출

2017년 4월 20일

처음 게시됨 (실제)

2017년 4월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 4월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 4월 20일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KMUHIRB-2011-05-01(II)

개별 참가자 데이터(IPD) 계획

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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