Clinical trial · Interventional
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)
NCT00055718CI-TRIAL-00013086completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug/Agent Toxicity by Tissue/Organ | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| silymarin | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Effect of silymarin on elevated liver function tests (AST, ALT, total bilirubin, and direct bilirubin) at baseline, day 28, and day 56
Secondary outcomes (2)
- measure
- Serum antioxidant capacity as measured by the Oxygen Radical Absorbance Capacity (ORAC) at baseline, day 28, and day 56
- measure
- Oxidative damage as measured by 8-oxodeoxyguanosine adducts at baseline, day 28, and day 56
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTLadas EJ, Kroll DJ, Oberlies NH, Cheng B, Ndao DH, Rheingold SR, Kelly KM. A randomized, controlled, double-blind, pilot study of milk thistle for the treatment of hepatotoxicity in childhood acute lymphoblastic leukemia (ALL). Cancer. 2010 Jan 15;116(2):506-13. doi: 10.1002/cncr.24723. PMID 20014183