Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247975
Status:
TERMINATED
Last Update Posted:
2022-08-16
First Post:
2005-10-31
Brief Title:
Ability of L-carnitine to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
Primary Prevention of Anthracycline-Induced Cardiotoxicity With L-Carnitine in Patients With Breast Cancer PPACC-Pilot Study
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast cancer is very common and afflicts 1 in 9 North American women The treatment of breast cancer often requires the use of chemotherapy including anthracyclines Anthracyclines can damage the heart resulting in heart failure and even death Clinicians and researchers are continually seeking methods that will reduce the toxic effects of anthracycline treatment
L-carnitine is a substance that is produced naturally in the body and is required for normal heart function Animal studies have suggested that L-carnitine protects the heart from the effects of anthracyclines however this has not been verified in humans
This study will assess the potential role of L-carnitine in the prevention of anthracycline induced heart damage The investigators will enroll 144 patients into this study Patients will be randomly assigned to L-carnitine therapy or to standard care no L-carnitine therapy Patients in the L-carnitine group will receive oral and intravenous L-carnitine prior to and after their anthracycline therapy Patients will undergo regular follow up and testing to assess heart function The investigators believe that patients treated with L-carnitine will benefit and have fewer complications associated with anthracycline treatment
L-carnitine is a substance that is produced naturally in the body and is required for normal heart function Animal studies have suggested that L-carnitine protects the heart from the effects of anthracyclines however this has not been verified in humans
This study will assess the potential role of L-carnitine in the prevention of anthracycline induced heart damage The investigators will enroll 144 patients into this study Patients will be randomly assigned to L-carnitine therapy or to standard care no L-carnitine therapy Patients in the L-carnitine group will receive oral and intravenous L-carnitine prior to and after their anthracycline therapy Patients will undergo regular follow up and testing to assess heart function The investigators believe that patients treated with L-carnitine will benefit and have fewer complications associated with anthracycline treatment
Detailed Description:
None
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