Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Objectives: Primary Objective: The primary end points are overall survival and cycles of salvage chemotherapy completed of malnourished patients in unresectable mGCs 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: Twenty patients are planed to be enrolled Drop out The following reasons may consider to withdrawing a patient from the study Intolerance adverse events Patient will exceed defined safety cut-off values e.g. increase of a certain amount of a laboratory parameter. Violation of study protocol Withdraw of informed consent. Study duration and dates The study of this protocol is expected to be approximately 24 months, with a subject recruitment period of 18 months (proposed to start in Sep 2014 and end in Sep 2018). The duration of the study or period of recruitment may vary. Treatment duration HPN is administered till resolution of malnutrition or till patient dies .

Official Title
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A Pilot Study of Home Parenteral Nutrition for Malnourished Patients With Unresectable Stage IV Gastric Receiving Salvage Chemotherapy

Conditions
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Metastatic Gastric Cancer

Intervention / Treatment
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* Other: Oliclinomel N4 Per bag 1.5 L
* Drug: Oxaliplatin
* Drug: 5Fluorouracil
* Drug: Leucovorin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histology confirmed adenocarcinoma of stomach. Stage IV (AJCC 7.0) Malnourished patients with nutritional risk index (NRI) < 97.5. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home parenteral nutrition<br>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. | Other: Oliclinomel N4 Per bag 1.5 L<br>* 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.<br>Drug: Oxaliplatin<br> <br> * Other names: Eloxatin;Drug: 5Fluorouracil<br> <br> * Other names: 5Fu;Drug: Leucovorin<br> <br> * Other names: folinic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from treatment to death of patients | three to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of salvage chemotherapy | Side effects of salvage chemotherapy are coded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | three to six months | 
| Quality of life before and after treatment | Quality of life is assessed with EORTC QLQ-C30 (version 3) questionnaire. | three to six months | 
| body weight in kilograms | body weight in kilograms | three to six months | 
| body mass index (BMI) in kg/m^2 | body mass index (BMI) in kg/m^2 | three to six months | 
| serum sugar in mg/dL | serum sugar in mg/dL | three to six months | 
| serum albumin in g/dL | serum albumin in g/dL | three to six months | 
| serum prealbumin in mg/dL | serum prealbumin in mg/dL | three to six months | 
| serum total protein in g/dL | serum total protein in g/dL | three to six months | 
| serum transferrin saturation in % | serum transferrin saturation in % | three to six months | 
| serum total cholesterol (TC) in mg/mL | serum total cholesterol (TC) in mg/mL | three to six months | 
| serum low-density lipoprotein cholesterol (LDL-C) in mg/mL | serum low-density lipoprotein cholesterol (LDL-C) in mg/mL | three to six months | 
| serum high-density lipoprotein cholesterol (HDL-C) in mg/mL | serum high-density lipoprotein cholesterol (HDL-C) in mg/mL | three to six months | 
| serum triglyceride (TG) in mg/dL | serum triglyceride (TG) in mg/dL | three to six months | 
| nitrogen balance in grams | nitrogen balance in grams | three to six months | 
| Performance status | Performance status is documented by Eastern Cooperative Oncology Group (ECOG) scale. | three to six months | 
| Interleukin 6 (IL-6) in pg/mL | Interleukin 6 (IL-6) in pg/mL | three to six months | 
| Interleukin 10 (IL-10) in pg/mL | Interleukin 10 (IL-10) in pg/mL | three to six months | 
| tumor necrosis factor-α (TNF-α) in pg/mL | tumor necrosis factor-α (TNF-α) in pg/mL | three to six months | 
| C-reactive protein (CRP) in mg/dL | C-reactive protein (CRP) in mg/dL | three to six months | 
| procalcitonin (PCT) in ng/mL | procalcitonin (PCT) in ng/mL | three to six months | 
| blood Na in mEq/L | blood Na in mEq/L | three to six months | 
| blood K in mEq/L | blood K in mEq/L | three to six months | 
| blood Ca in mg/dL | blood Ca in mg/dL | three to six months | 
| blood Cl in mEq/L | blood Cl in mEq/L | three to six months | 
| blood P in mg/dL | blood P in mg/dL | three to six months | 
| blood aspartate aminotransferase (AST) in U/L | blood aspartate aminotransferase (AST) in U/L | three to six months | 
| blood alanine aminotransferase (ALT) in U/L | blood alanine aminotransferase (ALT) in U/L | three to six months | 
| blood gamma-glutamyl transpeptidase (γGT) in U/L | blood gamma-glutamyl transpeptidase (γGT) in U/L | three to six months | 
| blood direct bilirubin in mg/dL | blood direct bilirubin in mg/dL | three to six months | 
| blood albumin in g/dL | blood albumin in g/dL | three to six months | 
| international normalized ratio (INR) | international normalized ratio (INR) | three to six months | 
| partial thromboplastin time (PTT) in seconds | partial thromboplastin time (PTT) in seconds | three to six months | 
| leukocyte-count in cells/μL | leukocyte-count in cells/μL | three to six months | 
| platelet-count in cells/μL | platelet-count in cells/μL | three to six months | 
| erythrocyte-count in cells/μL | erythrocyte-count in cells/μL | three to six months | 
| Complications of HPN | Complications of HPN include adverse events (AEs) and severe adverse events (SAEs). AEs and SAEs are coded using the MedDRA system (version 18.0, http://www.meddra.org) and summarized descriptively by system organ class. | three to six months | 
| Cycles of salvage chemotherapy completed | How many cycles of salvage chemotherapy for unresectable metastatic or recurrent gastric cancer is completed after intervention of HPN | three to six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home parenteral nutrition