JPRN-jRCTs031180294已完成未知
A randomized controlled trial to assess the efficacy and safety of RACOL for adverse events such as stomatitis and malnutrition during adjuvant chemotherapy of gastric cancer patients
Ogata Kyoichi0 个研究点目标入组 0 人开始时间: 2019年3月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
This study is a randomized controlled trial to assess the efficacy and safety of RACOL during adjuvant chemotherapy of gastric cancer patients. It was difficult to gather eligible patients. Finally, this study was finished without any registrant.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20age 至 75age（—）
- 性别
- All
入选标准
- •1) Patients who diagnosed as gastric cancer by cytology or histology.
- •2) Patients who will receive S-1 adjuvant chemotherapy.
- •3) Patients who diagnosed as Stage II-III gastric cancer.
- •4) Performance status (PS) 0 - 2.
- •5) Patients who don't receive chemotherapy or radiation.
- •6) Patients who can administer omega-3 fatty acid-containing enteral nutrition.
- •7) Patients whose function of main organ (bone marrow, heart, liver, kidney,lung, etc) are maintained and satisfy the following conditions.
- •White blood cell count >= 4,000/mm3, <= 12,000/mm3.
- •Neutrophils >= 2,000/mm3.
- •Blood platelet count >= 100,000/mm3.
- •Hemoglobin >= 9.5g/dl.
- •ALT, AST <= 1.5 times the upper limit of normal.
- •Total bilirubin <= 1.2mg/dl.
- •ALP <= 2.5 times the upper limit of normal.
- •Creatinine <= 1.2mg/dl.
- •BUN <= the upper limit of normal.
- •8) Patients with at least 3 months of life-expectancy.
- •9) Gender: unmentioned.
- •10) Inpatient admission or outpatient: unmentioned.
- •11) Signed, written informed concent is obtained.
排除标准
- •1) Patients with drug allergy of omega-3 fatty acid-containing enteral nutrition.
- •2) Patients with severe complications (heart disease, pulmonary fibrosis, interstitial pneumonia, bleeding tendency).
- •3) Patients with fever or severe infection.
- •4) Patients with active double cancer.
- •5) Patients with paralysis, peripheral neuropathy and edema.
- •6) Patients with active pleural or pericardial effusion.
- •7) Patients with severe drug allergy.
- •8) Patients who are pregnant, suspected to be pregnant or breastfeeding.
- •9) Patients with severe psychiatric disorder.
- •10) The patients with milk allergy.
- •11) The patients with ileus.
- •12) The patients without intestinal function.
- •13) The patients with severe liver or renal dysfunction.
- •14) The patients with severe diabetes mellitus.
- •15) The patients with congenital error of amino acid metabolism.
- •16) The patient who was considered ineligible by the investigators.
研究者
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