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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT00055718
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date November 2001
Completion date January 2010

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