Silymarin (Milk Thistle Extract) in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy
- Conditions
- Drug/Agent Toxicity by Tissue/OrganLeukemia
- Registration Number
- NCT00055718
- Lead Sponsor
- Herbert Irving Comprehensive Cancer Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of silymarin on elevated liver function tests (AST, ALT, total bilirubin, and direct bilirubin) at baseline, day 28, and day 56
- Secondary Outcome Measures
Name Time Method Serum antioxidant capacity as measured by the Oxygen Radical Absorbance Capacity (ORAC) at baseline, day 28, and day 56 Oxidative damage as measured by 8-oxodeoxyguanosine adducts at baseline, day 28, and day 56
Trial Locations
- Locations (8)
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada