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The objective of our study was to evaluate the expected cardioprotective effects of ketotifen due to its activity as an iron-chelating agent previously uncovered by us in the in vitro chemical test which included in the study, when used in patients receiving anthracyclines for the treatment of breast cancer. The study was a randomized : , prospective controlled trial : , and the patients were identified by coded numbers to maintain privacy. Eligible patients (111) fulfilled the criteria. Control Group: 55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen). Ketotifen Group: 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent. Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during the chemotherapeutic cycle for 6 cycles of treatment. Blood samples were obtained from all patients, and echocardiography two times for each patient at baseline and after 6 months (EF%).
The objective of our study was to evaluate the expected cardioprotective effects of ketotifen due to its activity as an iron-chelating agent previously uncovered by us in the in vitro chemical test which included in the study, when used in patients receiving anthracyclines for the treatment of breast cancer. The study was a randomized : , prospective controlled trial : , and the patients were identified by coded numbers to maintain privacy. Eligible patients (111) fulfilled the criteria. Control Group: 55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen). Ketotifen Group: 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent. Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during the chemotherapeutic cycle for 6 cycles of treatment. Blood samples were obtained from all patients, and echocardiography two times for each patient at baseline and after 6 months (EF%).
The aim is to prove and evaluate the prophylasis effect of ketotifin from cardiotoxicity induced by anthracyclines therapy without decreasing the anti-tumor action of anthracycline.
Because coronaviruses theoretically induce iron overload so, ketotifen has a potential beneficial effect in the management of COVID-19 as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | 55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen) |
| |
| ketotifen group | Ketotifen Group: 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent. Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during the chemotherapeutic cycle for 6 cycles of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketotifen 1 MG | Drug | Ketotifen is added to patients on anthracycline-containing chemotherapy for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| prophylaxis effect of Ketotifen on patient's hearts during the treatment of anthracyclines | the serum levels of LDH, CK-MB, troponin I, TIBC, ferritin, anti-cardiolipin IgG, and, iron were done | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
as the study was on breast cancer female patients
The study participants were recruited from the Oncology Department, Menoufia University Hospital, Egypt. The study was designed and conducted in compliance with the ethical principles of Good Clinical Practice Guidelines and the Declaration of Helsinki
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horus University | Damietta | Damiete Governonate | 12345 | Egypt |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D007665 | Ketotifen |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |