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NCT Number: NCT00055718

Silymarin (Milk Thistle Extract) in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy

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.

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Key information

Conditions

Drug/Agent Toxicity by Tissue/Organ Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 2 to 21

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • See Disease Characteristics

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • Not specified

Surgery

  • Not specified

Treatment and study plan

silymarin

Dietary Supplement

Primary outcomes

  1. Effect of silymarin on elevated liver function tests (AST, ALT, total bilirubin, and direct bilirubin) at baseline, day 28, and day 56

Secondary outcomes

  1. Serum antioxidant capacity as measured by the Oxygen Radical Absorbance Capacity (ORAC) at baseline, day 28, and day 56

  2. Oxidative damage as measured by 8-oxodeoxyguanosine adducts at baseline, day 28, and day 56

Sponsors and collaborators

Lead sponsor

Herbert Irving Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Study of Silymarin During Maintenance Therapy in Children With Acute Lymphoblastic Leukemia (ALL)

Important dates

Study start
2001
Study completion
2010
First posted
Mar 7, 2003
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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