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Stomach Neoplasms

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Oxaliplatin

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Folate

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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.

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.

Oliclinomel N4 Per bag 1.5 L

5Fluorouracil

Jaw-Yuan Jaw-Yuan, PhD

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.

Objectives:

1. 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:

Twenty patients are planed to be enrolled

Drop out The following reasons may consider to withdrawing a patient from the study

1. Intolerance adverse events
2. Patient will exceed defined safety cut-off values e.g. increase of a certain amount of a laboratory parameter.
3. Violation of study protocol
4. 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

.

Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer

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

Side effects of salvage chemotherapy are coded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Quality of life is assessed with EORTC QLQ-C30 (version 3) questionnaire.

serum low-density lipoprotein cholesterol (LDL-C) in mg/mL

serum high-density lipoprotein cholesterol (HDL-C) in mg/mL

Performance status is documented by Eastern Cooperative Oncology Group (ECOG) scale.

tumor necrosis factor-α (TNF-α) in pg/mL

blood aspartate aminotransferase (AST) in U/L

blood alanine aminotransferase (ALT) in U/L

blood gamma-glutamyl transpeptidase (γGT) in U/L

partial thromboplastin time (PTT) in seconds

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.

How many cycles of salvage chemotherapy for unresectable metastatic or recurrent gastric cancer is completed after intervention of HPN

Kaohsiung Medical University Chung-Ho Memorial Hospital

Professor

Behaviors and Mental Disorders

Quality of Life

Patients receiving home parenteral nutrition

Cancer Patients who are discharged on HPN will be monitored for quality of life, nutrition status, pain and nausea medication usage

Home Parenteral Nutrition

Ross Taylor, MD

This study is being done to examine the effect of Parenteral (intravenous) nutrition support in the home setting on quality of life in cancer patients. In addition, this study is being done to examine the effect of home parenteral nutrition on the use of pain and anti-nausea medication.

This is a prospective descriptive non-randomized clinical study to examine quality of life outcomes and use of pain and anti-emetic therapy for patients receiving HPN support. The EORTC QLQ-C30 will be used to evaluate quality of life. All subjects will be monitored monthly throughout the course of treatment for a minimum of 3 months and a maximum of 1 year.

Home Parenteral Nutrition in Cancer Patients

An Evaluation of Quality of Life Outcomes in Cancer Patients Receiving Home Parenteral

To examine the effect of parenteral nutrition support in the home care setting on quality of life as measured by the EORTC QLQ-C30

To examine the effect of home parenteral nutrition on the use of pain medication and anti-emetic therapy administered intravenously, subcutaneously, or orally.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer	NCT03121807	Metastatic Gast...	Oliclinomel N4 ... Oxaliplatin 5Fluorouracil Leucovorin	20 Years - 80 Years	Kaohsiung Medical University Chung-Ho Memorial Hospital
Home Parenteral Nutrition in Cancer Patients	NCT01152879	Cancer	Home Parenteral...	18 Years -	Southwestern Regional Medical Center
Home Parenteral Nutrition in Cancer Patients	NCT01152879	Cancer	Home Parenteral...	18 Years -	Southwestern Regional Medical Center

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