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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00055718

Enrollment

Registered

2003-03-07

Start date

2001-11-30

Completion date

2010-01-31

Last updated

2013-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug/Agent Toxicity by Tissue/Organ, Leukemia

Keywords

drug/agent toxicity by tissue/organ, childhood acute lymphoblastic leukemia

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.

Interventions

DIETARY_SUPPLEMENTsilymarin

Study design

Allocation

RANDOMIZED

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

2 Years to 21 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Effect of silymarin on elevated liver function tests (AST, ALT, total bilirubin, and direct bilirubin) at baseline, day 28, and day 56	—

Secondary

Measure	Time frame
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	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026