Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477607
Status:
COMPLETED
Last Update Posted:
2014-03-07
First Post:
2007-05-23
Brief Title:
Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Prevention of Cisplatin Ototoxicity With the Antioxidant Alpha-Lipoic Acid
Status:
COMPLETED
Status Verified Date:
2014-02
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:
RATIONALE Alpha-lipoic acid may prevent or lessen hearing loss caused by cisplatin
PURPOSE This randomized clinical trial is studying the effectiveness of alpha-lipoic acid in preventing hearing loss in cancer patients undergoing treatment with cisplatin
PURPOSE This randomized clinical trial is studying the effectiveness of alpha-lipoic acid in preventing hearing loss in cancer patients undergoing treatment with cisplatin
Detailed Description:
OBJECTIVES
Primary
Determine the ability of alpha-lipoic acid supplementation to prevent or reduce the incidence and severity of hearing loss in cancer patients undergoing treatment with cisplatin
Secondary
Determine if this drug improves the oxidative state as measured by a malondialdehyde measurement of oxidative stress thereby protecting the patient against ototoxic-induced hearing loss
OUTLINE This is a placebo-controlled double-blind randomized multicenter study Patients are stratified by cancer stage and institution Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral alpha-lipoic acid supplement once a day beginning 1 week before the start of cisplatin treatment and continuing for up to 1 month after the completion of cisplatin During cisplatin treatment patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment
Arm II Patients receive oral placebo supplement once a day beginning 1 week before the start of cisplatin and continuing for up to 1 month after the completion of cisplatin During cisplatin treatment patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment
Hearing and ototoxicity are assessed at baseline on each day of chemotherapy and at 1 and 3 months post chemotherapy
Blood samples are collected periodically to measure malondialdehyde and alpha-lipoic acid levels
After completion of treatment with cisplatin patients are followed for 3 months
Primary
Determine the ability of alpha-lipoic acid supplementation to prevent or reduce the incidence and severity of hearing loss in cancer patients undergoing treatment with cisplatin
Secondary
Determine if this drug improves the oxidative state as measured by a malondialdehyde measurement of oxidative stress thereby protecting the patient against ototoxic-induced hearing loss
OUTLINE This is a placebo-controlled double-blind randomized multicenter study Patients are stratified by cancer stage and institution Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral alpha-lipoic acid supplement once a day beginning 1 week before the start of cisplatin treatment and continuing for up to 1 month after the completion of cisplatin During cisplatin treatment patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment
Arm II Patients receive oral placebo supplement once a day beginning 1 week before the start of cisplatin and continuing for up to 1 month after the completion of cisplatin During cisplatin treatment patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment
Hearing and ototoxicity are assessed at baseline on each day of chemotherapy and at 1 and 3 months post chemotherapy
Blood samples are collected periodically to measure malondialdehyde and alpha-lipoic acid levels
After completion of treatment with cisplatin patients are followed for 3 months
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 |
|---|---|---|---|
| CDR0000546570 | OTHER_GRANT | None | None |
| NCRAR-VA-1810 | OTHER_GRANT | None | None |
| OHSU-3288 | OTHER_GRANT | VA RRD | None |