Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055718
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2003-03-06
Brief Title:
Silymarin Milk Thistle Extract in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study of Silymarin During Maintenance Therapy in Children With Acute Lymphoblastic Leukemia ALL
Status:
COMPLETED
Status Verified Date:
2006-05
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 Silymarin milk thistle extract is an herb that may be effective in treating liver disorders caused by cancer therapy
PURPOSE Randomized phase II trial to study the effectiveness of silymarin in treating patients who have acute lymphoblastic leukemia with chemotherapy-related side effects to the liver
PURPOSE Randomized phase II trial to study the effectiveness of silymarin in treating patients who have acute lymphoblastic leukemia with chemotherapy-related side effects to the liver
Detailed Description:
OBJECTIVES
Determine the effect of silymarin in terms of liver function tests in patients with acute lymphoblastic leukemia receiving hepatotoxic chemotherapy
Determine the effect of this drug on free and conjugated serum silibinin values in these patients
Determine the serum antioxidant capacity by Oxygen Radical Absorbance Capacity in patients treated with this drug
Determine the oxidative damage as determined by 8-oxodeoxyguanosine adducts in patients treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral silymarin daily for 28 days
Arm II Patients receive oral placebo as in arm I Patients are followed at day 56
PROJECTED ACCRUAL A total of 50 patients 25 per treatment arm will be accrued for this study
Determine the effect of silymarin in terms of liver function tests in patients with acute lymphoblastic leukemia receiving hepatotoxic chemotherapy
Determine the effect of this drug on free and conjugated serum silibinin values in these patients
Determine the serum antioxidant capacity by Oxygen Radical Absorbance Capacity in patients treated with this drug
Determine the oxidative damage as determined by 8-oxodeoxyguanosine adducts in patients treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral silymarin daily for 28 days
Arm II Patients receive oral placebo as in arm I Patients are followed at day 56
PROJECTED ACCRUAL A total of 50 patients 25 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CPMC-IRB-14117 | None | None | None |