Role of Silymarin in Chemotherapy Toxicity and Cognition Improvement in Breast Cancer Patients

• Status: Enrolling by invitation
• Trial end date: 2024-10-28
• Target enrollment: 0
• Participant gender: All

Summary

Aim of the work This study aims to evaluate the possible beneficial role of silymarin in attenuating both doxorubicin related cardiac and hepatic toxicities and paclitaxel associated peripheral neuropathy and improving cognitive impairment in patients with breast cancer.

This study will be a randomized placebo controlled parallel study. The study will be performed in accordance with the ethical standards of Helsinki declaration in 1964 and its later amendments.

Group one: (Placebo group; n=28) which will receive four cycles of AC regimen (doxorubicin and cyclophosphamide; each cycle was given every 21 day) followed by 12 cycles of paclitaxel (each cycle was given in a weekly basis) plus placebo tablets once daily.

Group two: (Silymarin group; n=28) which will receive the same regimen plus silymarin 140mg once daily

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Silymarin

Criteria

Inclusion Criteria:

• Age ≥ 18 years old.

• Patients with biopsy confirmed diagnosis breast cancer and with stage II and stage III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).

• Patients with performance status <2 according to Eastern Cooperative Oncology Group (ECOG) score.

• Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl).

• Patients with adequate liver function (serum bilirubin < 1.2 mg/dl) and adequate renal function (serum creatinine< 1.5 mg/d).

Exclusion Criteria:

• Patients with prior exposure to anthracyclines and neurotoxic agents (Cis-platin, vincristine, paclitaxel, docetaxel, foscarnet ,INH, etc..) in the last 6 months.

• Patients with evidence of metastasis at the initial assessment.

• Concomitant use of antioxidant vitamins (vitamin A, C, E),anticonvulsants, tricyclic antidepressants, other medications used for neuropathic pain (gabapentin, lamotrigine, carbamazepine).

• Presence of clinical evidence for severe cardiac illness (angina pectoris, uncontrolled hypertension, arrhythmias and left ventricular ejection fraction <50%).

• Preexisting peripheral neuropathy resulting from other causes such as diabetes and brain disorders, hypothyroidism, autoimmune diseases, hepatitis C.

• Patients with diabetes.

• Patients with inflammatory diseases (ulcerative colitis, rheumatoid arthritis).

• Patients with conditions associated with oxidative stress (smoking, tuberculosis, obesity).

• Patients with liver disease (fatty liver, hepatitis C, etc..).

• Patients who are candidates for monoclonal antibodies such as Trastuzumab and other targeted therapy (HER2 positive patients).

• Pregnant and breast feeding women.