Ignite Creation Date:
2024-05-06 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03121807
Status:
COMPLETED
Last Update Posted:
2019-06-21
First Post:
2017-01-04
Brief Title:
Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Overview
Official Title:
A Pilot Study of Home Parenteral Nutrition for Malnourished Patients With Unresectable Stage IV Gastric Receiving Salvage Chemotherapy
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None