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Trial Title:
Effect of Silymarin in Metastatic Colorectal Cancer Patients
NCT ID:
NCT05631041
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Silymarin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Silymarin
Description:
participants in silymarin group will receive silymarin 140 mg once daily.
Arm group label:
Silymarin group
Summary:
this work is aim to assess the antitumor effect of silymarin in patients with metastatic
colorectal cancer receiving chemotherapy with or without target therapy (Bevacizumab).
Detailed description:
Colorectal cancer (CRC) ranks as the third most common cancer globally and second in
terms of mortality . Although CRC incidence rates are higher in high-income compared with
low-to-middle-income countries (LMICs), mortality is higher in LMICs.
Extensive research within the last decade has shown that silymarin can suppress the
proliferation of a variety of tumor cells; this is accomplished through cell cycle arrest
at the G1/S-phase, induction of cyclin-dependent kinase inhibitors, down-regulation of
anti- apoptotic gene products, inhibition of cell-survival kinases and inhibition of
inflammatory transcription factors (e.g., Nuclear Factor- kappa B) through suppression of
Nuclear Factor- kappa B-regulated gene products, including Cyclooxygenase-2,
Lipoxygenase, Tumor necrosis factor and Interleukin-1. Silymarin can also down-regulate
gene products involved in the proliferation of tumor cells (Epidermal Growth Factor
Receptor, Cyclooxygenase-2), invasion (Matrix metallopeptidase 9), angiogenesis (Vascular
Endothelial growth Factor) and metastasis (adhesion molecules). Silymarin was reported to
alter the expression of apoptosis-related proteins including BCL2 associated X protein to
induce apoptosis in human gastric cancer cells in a concentration-dependent manner.
Silymarin has also been shown to sensitize tumors to chemotherapeutic agents through
down-regulation of the Multidrug resistance protein and other mechanisms. In addition to
its chemo-preventive effects, silymarin exhibits antitumor activity against human tumors
in rodents. so we aim to assess the antitumor activity of silymarin in metastatic
colorectal cancer patients receiving chemotherapy.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
faculty of Pharmacy , Tanta University
Address:
City:
Tanta
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
faculty of Pharmacy
Phone:
0403336007
Email:
dean@pharm.tanta.edu.eg
Start date:
December 31, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Tanta University
Agency class:
Other
Source:
Tanta University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05631041
