Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02150447
Status:
TERMINATED
Last Update Posted:
2018-04-04
First Post:
2014-05-26
Brief Title:
The Use of Proton Pump Inhibitor on the Prevention of Gastric Cancer Bleeding
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
Effect of Proton Pump Inhibitor on Prevention of Tumor Bleeding in Patients Under Palliative Chemotherapy for Unresectable Gastric Cancer a Randomized Double Blind and Placebo Controlled Multicenter Trial
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enroll rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is the effect of proton pump inhibitor PPI with respect to gastric cancer bleeding in inoperable patients
Detailed Description:
Tumor bleeding frequently occurs in inoperable gastric cancer patients Inoperable gastric cancer usually has a large ulcer with friable tumor vessels Acidic environment in stomach prevents adequate function of coagulation cascade and decrease clot stability Gastric cancer bleeding may cause significant morbidity and often delays scheduled chemotherapy National Center Center data showed that about 30 of gastric cancer patient undergoing palliative chemotherapy eventually experience significant cancer bleeding during the treatment period Once bleeding occurs endoscopic management is more difficult in gastric cancer patients than in patients with benign peptic ulcers because the malignant ulcer bed has significant fibrosis Consequently gastric cancer patient has a high risk of rebleeding
Proton pump inhibitor PPI lansoprazole for example decrease gastric acid secretion by inhibiting HK-ATPase and subsequently stabilize blood clot PPIs are commonly used for benign peptic ulcer or reflux esophagitis and PPI can decrease recurrent benign ulcer bleeding or other ulcer complications Moreover it was reported to prevent bleeding from NSAID or aspirin induced gastric ulcer Because PPIs are very safe and they are even available as over-the-counter drugs in some countries Furthermore the drug has no interaction with major chemotherapeutic agents commonly used for gastric cancer Moreover the drugs are prescribed to the gastric cancer patients when tumor bleeding occurs Although gastric cancer bleeding is not uncommon and clinically challenging problem there has been no recommended measure to prevent cancer bleeding Also there has been no report about the efficacy of PPIs on the gastric cancer bleeding prevention up to now
Proton pump inhibitor PPI lansoprazole for example decrease gastric acid secretion by inhibiting HK-ATPase and subsequently stabilize blood clot PPIs are commonly used for benign peptic ulcer or reflux esophagitis and PPI can decrease recurrent benign ulcer bleeding or other ulcer complications Moreover it was reported to prevent bleeding from NSAID or aspirin induced gastric ulcer Because PPIs are very safe and they are even available as over-the-counter drugs in some countries Furthermore the drug has no interaction with major chemotherapeutic agents commonly used for gastric cancer Moreover the drugs are prescribed to the gastric cancer patients when tumor bleeding occurs Although gastric cancer bleeding is not uncommon and clinically challenging problem there has been no recommended measure to prevent cancer bleeding Also there has been no report about the efficacy of PPIs on the gastric cancer bleeding prevention up to now
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 |
|---|---|---|---|
| 1210520 | OTHER_GRANT | National Cancer Center Korea | None |
| 0910090 | OTHER_GRANT | None | None |