Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04435028
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2020-06-15
Brief Title:
Ketotifen as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy
Sponsor:
Horus University
Organization:
Horus University
Study Overview
Official Title:
Ketotifen Novel Use as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy as Well as the Potential Beneficial Effects of Ketotifen in the Hypothetical Management of COVID-19
Status:
COMPLETED
Status Verified Date:
2020-06
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:
The objective of our study was to evaluate the expected cardioprotective effects of ketotifen due to its activity as an iron-chelating agent previously uncovered by us in the in vitro chemical test which included in the study when used in patients receiving anthracyclines for the treatment of breast cancer The study was a randomized prospective controlled trial and the patients were identified by coded numbers to maintain privacy Eligible patients 111 fulfilled the criteria Control Group 55 patients received their standard therapy anthracycline-containing chemotherapy without ketotifen Ketotifen Group 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent Ketotifen will be given orally as one tablet 1 mgtablet 3 times daily before and during the chemotherapeutic cycle for 6 cycles of treatment Blood samples were obtained from all patients and echocardiography two times for each patient at baseline and after 6 months EF
Detailed Description:
The objective of our study was to evaluate the expected cardioprotective effects of ketotifen due to its activity as an iron-chelating agent previously uncovered by us in the in vitro chemical test which included in the study when used in patients receiving anthracyclines for the treatment of breast cancer The study was a randomized prospective controlled trial and the patients were identified by coded numbers to maintain privacy Eligible patients 111 fulfilled the criteria Control Group 55 patients received their standard therapy anthracycline-containing chemotherapy without ketotifen Ketotifen Group 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent Ketotifen will be given orally as one tablet 1 mgtablet 3 times daily before and during the chemotherapeutic cycle for 6 cycles of treatment Blood samples were obtained from all patients and echocardiography two times for each patient at baseline and after 6 months EF
The aim is to prove and evaluate the prophylasis effect of ketotifin from cardiotoxicity induced by anthracyclines therapy without decreasing the anti-tumor action of anthracycline
Because coronaviruses theoretically induce iron overload so ketotifen has a potential beneficial effect in the management of COVID-19 as well
The aim is to prove and evaluate the prophylasis effect of ketotifin from cardiotoxicity induced by anthracyclines therapy without decreasing the anti-tumor action of anthracycline
Because coronaviruses theoretically induce iron overload so ketotifen has a potential beneficial effect in the management of COVID-19 as well
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None