Silymarin (Milk Thistle Extract) in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|