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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
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

March 6, 2003
March 7, 2003
December 18, 2013
November 2001
Not Provided
Effect of silymarin on elevated liver function tests (AST, ALT, total bilirubin, and direct bilirubin) at baseline, day 28, and day 56
Not Provided
Complete list of historical versions of study NCT00055718 on ClinicalTrials.gov Archive Site
  • 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
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Silymarin (Milk Thistle Extract) in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy
A Pilot Study of Silymarin During Maintenance Therapy in Children With Acute Lymphoblastic Leukemia (ALL)

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.


  • 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.

Phase 2
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
  • Drug/Agent Toxicity by Tissue/Organ
  • Leukemia
Dietary Supplement: silymarin
Not Provided
Ladas EJ, Kroll DJ, Oberlies NH, Cheng B, Ndao DH, Rheingold SR, Kelly KM. A randomized, controlled, double-blind, pilot study of milk thistle for the treatment of hepatotoxicity in childhood acute lymphoblastic leukemia (ALL). Cancer. 2010 Jan 15;116(2):506-13. doi: 10.1002/cncr.24723.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2010
Not Provided


  • Diagnosis of acute lymphoblastic leukemia (ALL)
  • Currently receiving maintenance or continuation phase chemotherapy for ALL

    • Regimen comprising intrathecal and oral methotrexate; vincristine IV; oral prednisone or dexamethasone; and oral mercaptopurine
  • Elevated liver function tests, evidenced by 1 of the following criteria:

    • Bilirubin greater than 1.5 times upper limit of normal (ULN)
    • AST greater than 2.5 times ULN
    • ALT greater than 2.5 times ULN



  • 2 to 21

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • See Disease Characteristics


  • Not specified


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • See Disease Characteristics


  • Not specified


  • Not specified
Sexes Eligible for Study: All
2 Years to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
Not Provided
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Not Provided
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Kara Kelly, MD Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP