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- Ensaio Clínico NCT03123432
Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer
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)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Kaohsiung, Taiwan, 807
- Chung-Ho Memorial Hospital, Kaohsiung Medical University:
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
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Outros nomes:
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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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immunomodulating effects
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
blood glucose
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Investigadores
- Cadeira de estudo: Jaw-Yuan Wang, PhD, Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KMUHIRB-2011-05-01(II)
Plano para dados de participantes individuais (IPD)
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