A Pilot Study of Home Parenteral Nutrition for Malnourished Patients With Unresectable Stage IV Gastric Receiving Salvage Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This survey is a single arm study to assess the effect of home parenteral nutrition on overall survival, cycles of salvage chemotherapy completed, side effects of salvage chemotherapy, quality of life, nutritional status, functional status, inflammatory status and complications of HPN in malnourished unresectable metastatic gastric cancer (mGC) patients in a single medical center. It is expected that about 20 subjects will be recruited during an estimated period of 48 months.
详细描述
Objectives:
- Primary Objective:
The primary end points are overall survival and cycles of salvage chemotherapy completed of malnourished patients in unresectable mGCs 2. Secondary Objectives:
Side effects of salvage chemotherapy, quality of life, nutritional status, performance status, inflammatory status, safety and complications of HPN. The visit time schedules are at the time of enrollment before HPN is delivered, and at the beginning of every cycle of salvage chemotherapy
Patient Selection and Enrollment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology confirmed adenocarcinoma of stomach.
- •Stage IV (AJCC 7.0)
- •Malnourished patients with nutritional risk index (NRI) < 97.
- •NRI= 1.59 x serum albumin level (g/L) + 0.417 x (current weight/usual weight) x 100
- •Adequate organ function as defined by the following criteria:
- •absolute neutrophil count (ANC) > or =1500 cells/mm3;
- •platelets > or =60,000 cells/mm3
- •hemoglobin > or =8.0 g/dL
- •AST and ALT < or =3.0 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT< or =5.0 x ULN;
- •total bilirubin < or =2.0x ULN
- •serum creatinine < or =2.0 x ULN or calculated creatinine clearance > or =60 mL/min
- •Male or female, age > or = 20 years and < 80 years.
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment.
- •Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
排除标准
- •Known allergy to components of studied parenteral nutrition.
- •Acute shock or collapse.
- •Known diabetic ketoacidosis 7 days prior to randomization.
- •Unstable conditions (e.g. uncompensated diabetes mellitus, acute myocardial infarction, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration).
- •General contraindications to infusion therapy: acute pulmonary edema, hyperhydration, uncompensated cardiac insufficiency.
- •Investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complications)
- •Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
- •Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
- •Participation in another clinical study with an investigational drug or an investigational medical device within 1 month prior to start of the study or during the study.
- •Female patients who are pregnant or lactating, or men and women of reproductive potential not willing or not able to employ an effective method of birth control/contraception to prevent pregnancy during treatment and for 6 months after discontinuing study treatment. The definition of effective contraception should be in agreement with local regulation and based on the judgment of the principal investigator or a designated associate.
研究组 & 干预措施
Home parenteral nutrition
Home parenteral nutrition with 910 kcal/day , including 33 g amino acid/day, 120 g glucose/day, 30 g lipid/day and electrolyte, micro-element and vitamin according to the nutritional status of subjects and followed the standard procedure of the hospital (Oliclinomel N4 Per bag 1.5 L), was infused continuously daily in an infusion time ranged between 18-24 hours.
Patients received 85 mg/m2 oxaliplatin and 200 mg/m2 leucovorin as a 2-h intravenous infusion on day 1, followed by 2400 mg/m2 5Fluorouracil as a 46-h continuous infusion. This regimen is repeated every 14 days as a cycle.
干预措施: Oliclinomel N4 Per bag 1.5 L (Other)
Home parenteral nutrition
Home parenteral nutrition with 910 kcal/day , including 33 g amino acid/day, 120 g glucose/day, 30 g lipid/day and electrolyte, micro-element and vitamin according to the nutritional status of subjects and followed the standard procedure of the hospital (Oliclinomel N4 Per bag 1.5 L), was infused continuously daily in an infusion time ranged between 18-24 hours.
Patients received 85 mg/m2 oxaliplatin and 200 mg/m2 leucovorin as a 2-h intravenous infusion on day 1, followed by 2400 mg/m2 5Fluorouracil as a 46-h continuous infusion. This regimen is repeated every 14 days as a cycle.
干预措施: Oxaliplatin (Drug)
Home parenteral nutrition
Home parenteral nutrition with 910 kcal/day , including 33 g amino acid/day, 120 g glucose/day, 30 g lipid/day and electrolyte, micro-element and vitamin according to the nutritional status of subjects and followed the standard procedure of the hospital (Oliclinomel N4 Per bag 1.5 L), was infused continuously daily in an infusion time ranged between 18-24 hours.
Patients received 85 mg/m2 oxaliplatin and 200 mg/m2 leucovorin as a 2-h intravenous infusion on day 1, followed by 2400 mg/m2 5Fluorouracil as a 46-h continuous infusion. This regimen is repeated every 14 days as a cycle.
干预措施: 5Fluorouracil (Drug)
Home parenteral nutrition
Home parenteral nutrition with 910 kcal/day , including 33 g amino acid/day, 120 g glucose/day, 30 g lipid/day and electrolyte, micro-element and vitamin according to the nutritional status of subjects and followed the standard procedure of the hospital (Oliclinomel N4 Per bag 1.5 L), was infused continuously daily in an infusion time ranged between 18-24 hours.
Patients received 85 mg/m2 oxaliplatin and 200 mg/m2 leucovorin as a 2-h intravenous infusion on day 1, followed by 2400 mg/m2 5Fluorouracil as a 46-h continuous infusion. This regimen is repeated every 14 days as a cycle.
干预措施: Leucovorin (Drug)
结局指标
主要结局
Overall survival
时间窗: three to six months
Time from treatment to death of patients
次要结局
- blood Ca in mg/dL(three to six months)
- blood Cl in mEq/L(three to six months)
- blood P in mg/dL(three to six months)
- Side effects of salvage chemotherapy(three to six months)
- Quality of life before and after treatment(three to six months)
- body weight in kilograms(three to six months)
- body mass index (BMI) in kg/m^2(three to six months)
- serum sugar in mg/dL(three to six months)
- serum albumin in g/dL(three to six months)
- serum prealbumin in mg/dL(three to six months)
- serum total protein in g/dL(three to six months)
- serum transferrin saturation in %(three to six months)
- blood aspartate aminotransferase (AST) in U/L(three to six months)
- serum total cholesterol (TC) in mg/mL(three to six months)
- serum low-density lipoprotein cholesterol (LDL-C) in mg/mL(three to six months)
- serum high-density lipoprotein cholesterol (HDL-C) in mg/mL(three to six months)
- serum triglyceride (TG) in mg/dL(three to six months)
- nitrogen balance in grams(three to six months)
- Performance status(three to six months)
- Interleukin 6 (IL-6) in pg/mL(three to six months)
- Interleukin 10 (IL-10) in pg/mL(three to six months)
- tumor necrosis factor-α (TNF-α) in pg/mL(three to six months)
- C-reactive protein (CRP) in mg/dL(three to six months)
- procalcitonin (PCT) in ng/mL(three to six months)
- blood Na in mEq/L(three to six months)
- blood K in mEq/L(three to six months)
- blood alanine aminotransferase (ALT) in U/L(three to six months)
- blood gamma-glutamyl transpeptidase (γGT) in U/L(three to six months)
- blood direct bilirubin in mg/dL(three to six months)
- blood albumin in g/dL(three to six months)
- international normalized ratio (INR)(three to six months)
- partial thromboplastin time (PTT) in seconds(three to six months)
- leukocyte-count in cells/μL(three to six months)
- platelet-count in cells/μL(three to six months)
- erythrocyte-count in cells/μL(three to six months)
- Complications of HPN(three to six months)
- Cycles of salvage chemotherapy completed(three to six months)
研究者
Jaw-Yuan Wang, MD, PhD
Professor
Kaohsiung Medical University Chung-Ho Memorial Hospital