Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT00055718
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.
Study:
NCT00055718
Study Brief:
Protocol Section:
NCT00055718