Clinical trial

The Possible Anticancer Effect of Silymarin in Patients With Metastatic Colorectal Cancer Receiving Chemotherapy.

Name

Silymarin in Colorectal Cancer

Description

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).

Trial arms

Trial start

2022-12-31

Estimated PCD

2024-11-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Silymarin

participants in silymarin group will receive silymarin 140 mg once daily.

Arms:

Silymarin group

Size

Primary endpoint

The change between groups in response rate (RECIST)

At baseline, pre-intervention and at the end of last chemotherapy cycle ( 3 months from the beginning ) patients will recieve either Folfiri 6 cycles ( each cycle is 14 days) or Xeliri 4 cycles ( each cycle is 21 days)

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 64, 'type': 'ESTIMATED'}}

Updated at

2023-12-22

1 organization

1 product

1 indication

Organization

Tanta University

Product

Silymarin

Indication

Colorectal Cancer