NCT03121807

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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 .

Conditions

• Metastatic Gastric Cancer

Interventions

Type	Name	Description
OTHER	Oliclinomel N4 Per bag 1.5 L	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.
DRUG	Oxaliplatin
DRUG	5Fluorouracil
DRUG	Leucovorin

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-04-01
• Completion: 2019-06-01
• First posted: 2017-04-20
• Last updated: 2019-06-21

Locations

1 site across 1 country: Taiwan