Using Silymarin to Treat Metastatic Colorectal Cancer
The Possible Anticancer Effect of Silymarin in Patients With Metastatic Colorectal Cancer Receiving Chemotherapy.
PHASE3 · Tanta University · NCT05631041
This study is testing if adding silymarin to chemotherapy can help improve treatment results for adults with metastatic colorectal cancer.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University (other) |
| Drugs / interventions | chemotherapy, Bevacizumab |
| Locations | 1 site (Tanta) |
| Trial ID | NCT05631041 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the antitumor effects of silymarin in patients with metastatic colorectal cancer who are undergoing chemotherapy, with or without the addition of targeted therapy using Bevacizumab. The study will involve patients who have received specific first-line chemotherapy regimens (FOLFOX or XELOX) and will assess various biological mechanisms through which silymarin may enhance treatment efficacy. The trial will include patients aged 18 and older with confirmed metastatic colorectal carcinoma and adequate organ function. The primary focus is to determine if silymarin can improve outcomes in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed metastatic colorectal cancer who have received FOLFOX or XELOX chemotherapy.
Not a fit: Patients with active liver diseases, a history of other malignancies, or those with brain metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option that enhances the effectiveness of existing chemotherapy for metastatic colorectal cancer patients.
How similar studies have performed: While there is extensive research on silymarin's effects on various tumor cells, this specific application in metastatic colorectal cancer is novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * - Patients with histologically and/or radiologically confirmed diagnosis of metastatic colorectal carcinoma. * Patients who received FOLFOX or XELOX as first line chemotherapy * Both genders. * Age ≥18 years old. * Performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG). * Patients with adequate hematologic parameters (white blood cell count ≥3000/mm3, granulocytes ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥ 8 gm/l). * Patients with adequate renal functions (serum creatinine ≤1.5 mg/dL). * Patients with adequate hepatic functions (bilirubin ≤1.5 mg/dL or albumin ≥3 g/dL). Exclusion Criteria: * - Patients with active liver diseases (chronic viral hepatitis, autoimmune hepatitis, alcoholic hepatitis, Wilson's disease, hemochromatosis, or cirrhosis). * Patients with a history of other malignancy. * Patients with brain metastasis. * Patients with active infection. * Patients with RAS wild type cancer. * Patients on chronic use of corticosteroids.
Where this trial is running
Tanta
- faculty of Pharmacy , Tanta University — Tanta, Egypt (RECRUITING)
Study contacts
- Principal investigator: shimaa yassin, pharmacist — Tanta University
- Study coordinator: Shimaa Yassin, pharmacist
- Email: shaimaa150849@pharm.tanta.edu.eg
- Phone: 01003228294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Colorectal Cancer