Breast Cancer Clinical Trial
Official title:
The Possible Protective Role of Silymarin Against Chemotherapy Induced Toxicities and Cognitive Impairment in Breast Cancer Patients
Verified date | October 2022 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Enrolling by invitation |
Enrollment | 56 |
Est. completion date | October 28, 2024 |
Est. primary completion date | April 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta university | Tanta |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Abd Eldaim MA, Barakat ER, Alkafafy M, Elaziz SAA. Antioxidant and anti-apoptotic prophylactic effect of silymarin against lead-induced hepatorenal toxicity in rats. Environ Sci Pollut Res Int. 2021 Nov;28(41):57997-58006. doi: 10.1007/s11356-021-14722-8. Epub 2021 Jun 8. — View Citation
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Klein I, Lehmann HC. Pathomechanisms of Paclitaxel-Induced Peripheral Neuropathy. Toxics. 2021 Sep 22;9(10). pii: 229. doi: 10.3390/toxics9100229. Review. — View Citation
Prasanna PL, Renu K, Valsala Gopalakrishnan A. New molecular and biochemical insights of doxorubicin-induced hepatotoxicity. Life Sci. 2020 Jun 1;250:117599. doi: 10.1016/j.lfs.2020.117599. Epub 2020 Mar 29. Review. — View Citation
Rawat PS, Jaiswal A, Khurana A, Bhatti JS, Navik U. Doxorubicin-induced cardiotoxicity: An update on the molecular mechanism and novel therapeutic strategies for effective management. Biomed Pharmacother. 2021 Jul;139:111708. doi: 10.1016/j.biopha.2021.111708. Epub 2021 May 13. Review. — View Citation
Shokouhi G, Kosari-Nasab M, Salari AA. Silymarin sex-dependently improves cognitive functions and alters TNF-a, BDNF, and glutamate in the hippocampus of mice with mild traumatic brain injury. Life Sci. 2020 Sep 15;257:118049. doi: 10.1016/j.lfs.2020.118049. Epub 2020 Jul 4. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in ejection fraction | Doxorubicin related cardiotoxicity will be assessed through :Echocardiography at baseline, Before starting the first chemotherapy cycle (baseline), after the last AC cycle (for assessment of N-terminal prohormone of brain naturetic peptide "NT-proBNP" ) and after the last doxorubicin/ cyclophosphamide (AC) cycle. | 6 months | |
Primary | change in percentage of patients with peripheral sensory neuropathy | change in percentage of patients with peripheral sensory neuropathy grade = 2 with the variation of both 12-item neurotoxicity questionnaire (Ntx-12) total score and pain rating scale score. | 6 months | |
Secondary | changes in serum levels of the measured biological markers. | N-terminal prohormone of brain naturetic peptide "NT-proBNP" ) liver panel myeloperoxidase (MPO) neurofilament light chain (NFL) nuclear factor- Kabba B p65 (NF-?B p65) or TNF-alpha | 6 months |
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