Ignite Creation Date:
2024-05-06 @ 1:52 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01917617
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2013-08-04
Brief Title:
Oral Rehydration Therapy for Short Hydration in Chemotherapy With CDDP Plus GEM for Biliary Tract Cancer
Sponsor:
Kansai Hepatobiliary Oncology Group
Organization:
Kansai Hepatobiliary Oncology Group
Study Overview
Official Title:
The Feasibility Study of Oral Rehydration Therapy for Short Hydration in Chemotherapy With Cisplatin Plus Gemcitabine for Biliary Tract Cancer
Status:
COMPLETED
Status Verified Date:
2017-05
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:
The objective of this study is to evaluate the safety and feasibility of oral rehydration therapy for short hydration in patients with biliary tract cancer who will undergo the chemotherapy including gemcitabine and cisplatin
Detailed Description:
A large amount of fluid infusion is required to load for the prevention of renal dysfunction by Cisplatin in combination of GC therapy There is a problem infusion time is take a long time for this In many institutions in Japan GC therapy is performed over 3 hours or more longer than original method in the ABC-002 trial Oral rehydration therapy is a therapy that performs prevention or treatment of dehydration by the ingestion of oral rehydration solution which is adjusted the concentration of the electrolyte and glucose to absorb good efficiency from the gastrointestinal tract Oral rehydration therapy ORT is a therapy that performs prevention or treatment of dehydration by the ingestion of oral rehydration solution which is adjusted the concentration of the electrolyte and glucose to absorb good efficiency from the gastrointestinal tract Many reports suggest ORT may substitute for infusion therapy Herein the investigators planned the study to examine the safety of replacing the fluid infusion by oral rehydration expecting to shorten the time to drip
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMIN000010695 | REGISTRY | UMIN | None |