NCT00055718

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Herbert Irving Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug/Agent Toxicity by Tissue/Organ
• Leukemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	silymarin

Timeline

• Start date: 2001-11-01
• Completion: 2010-01-01
• First posted: 2003-03-07
• Last updated: 2013-12-18

Locations

8 sites across 2 countries: United States, Canada