Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003599
Status:
WITHDRAWN
Last Update Posted:
2012-02-22
First Post:
1999-11-01
Brief Title:
Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Study of the Effect of Alpha-tocopherol AT on 13-cis-retinoic Acid 13-cRA Toxicity in a Preliminary Chemoprevention Trial in Former and Current Smokers
Status:
WITHDRAWN
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of isotretinoin may be an effective way to prevent lung cancer Vitamin E may prevent the side effects of isotretinoin therapy
PURPOSE Randomized clinical trial to study the effectiveness of vitamin E in preventing the side effects of isotretinoin in former and current smokers who are receiving isotretinoin to prevent lung cancer
PURPOSE Randomized clinical trial to study the effectiveness of vitamin E in preventing the side effects of isotretinoin in former and current smokers who are receiving isotretinoin to prevent lung cancer
Detailed Description:
OBJECTIVES I Determine whether the addition of alpha-tocopherol AT vitamin E to isotretinoin decreases the incidence of Grade II and higher toxicity of isotretinoin when administered to former and current smokers II Determine the compliance rate of isotretinoin of smoker and former smokers with or without AT over a six month period III Determine the feasibility of recruiting former and current smokers with or without AT over a six month period IV Determine the effect of isotretinoin administration on serum retinol and retinol-binding protein levels in these patients
OUTLINE This is randomized placebo controlled study Patients are stratified by smoking status current smoker vs former smoker and age less than 50 vs 50 and over Patients are randomized to be take alpha-tocopherol AT orally and isotretinoin orally daily arm I or isotretinoin orally plus AT placebo orally daily arm II Treatment in each arm continues for 6 months Patients are followed at 1 3 6 and 7 months from start of treatment
PROJECTED ACCRUAL There will be 300 patients 150 per arm accrued into this study over an estimated 9 months
OUTLINE This is randomized placebo controlled study Patients are stratified by smoking status current smoker vs former smoker and age less than 50 vs 50 and over Patients are randomized to be take alpha-tocopherol AT orally and isotretinoin orally daily arm I or isotretinoin orally plus AT placebo orally daily arm II Treatment in each arm continues for 6 months Patients are followed at 1 3 6 and 7 months from start of treatment
PROJECTED ACCRUAL There will be 300 patients 150 per arm accrued into this study over an estimated 9 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 |
|---|---|---|---|
| CDR0000066672 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-DM-97078 | OTHER | None | None |
| NCI-P98-0132 | None | None | None |