Silymarin (Milk Thistle Extract) in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy
|ClinicalTrials.gov Identifier: NCT00055718|
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Drug/Agent Toxicity by Tissue/Organ Leukemia||Dietary Supplement: silymarin||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Study of Silymarin During Maintenance Therapy in Children With Acute Lymphoblastic Leukemia (ALL)|
|Study Start Date :||November 2001|
|Actual Study Completion Date :||January 2010|
- Effect of silymarin on elevated liver function tests (AST, ALT, total bilirubin, and direct bilirubin) at baseline, day 28, and day 56
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055718
|United States, Florida|
|Miami Children's Hospital|
|Miami, Florida, United States, 33155|
|United States, New York|
|Winthrop University Hospital|
|Mineola, New York, United States, 11501|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|United States, Ohio|
|Children's Hospital Medical Center of Akron|
|Akron, Ohio, United States, 44308-1062|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105-3916|
|McMaster Children's Hospital at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Study Chair:||Kara Kelly, MD||Herbert Irving Comprehensive Cancer Center|