Clinical trial · Interventional
The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment
NCT03130634CI-TRIAL-00045082completedPhase 4ClinicalTrials.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)
Primary objectives: Use both listed and relatively safe drug, Silymarin,s to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Silymarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- prescription of silymarin
- description
- During six cycles of FOLFIRI chemotherapy, the patients will take silymarin (150mg) three times daily from day 1 to day 7 during one cycle of treatment.
- interventionNames
- Drug: Silymarin
- type
- NO_INTERVENTION
- label
- control
- description
- During six cycles of FOLFIRI chemotherapy, the patients will not take silymarin during chemotherapy
Primary outcomes (1)
- measure
- GI associated adverse events
- timeFrame
- 3 months
- description
- Response rate and grades of GI associated adverse events (AEs) according to the Response Evaluation Criteria in Solid Tumors (version 1.1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient who is between 20 to 80 years old 2. The patient who is diagnosed metastatic colorectal cancer and received chemotherapy with FOLFIRI regimen 3. The female patient should not be pregnant or breast-feeding 4. The patient who has no severe co-morbidity, such as cardiovascular, cerebrovascular, malignant hypertension, renal and hepatobiliary disease. 5. The patient who has no associated drug allergy to this trial. 6. The patient who is in compliance with prescribed medication. 7. The patient who is willing to sign the permit of the clinical trial. Exclusion Criteria: 1. The patients who do not meet the main inclusion criteria or are not willing to sign the permit. 2. The patient who has viral hepatitis or carrier with impaired liver function.
References
Publications (0)
Data not yet available
No reference posted for this study.