Ketotifen: as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy

Horus University

Status: Completed

Conditions: Breast Cancer; Iron Chelation

Treatments: Drug: Ketotifen 1 MG

Study type: Observational

Funder types: Other

Identifiers

NCT04435028

1890-1-2019

Details and patient eligibility

About

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%).

Full description

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.

Enrollment: 111 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cancer patients receiving anthracycline chemotherapy in their protocol alone (without any cardioprotective agent),
• aged 30-60, and
• female subjects were included as they were female breast cancer patients, and,
• patients who had an adequate baseline echocardiography.

Exclusion criteria

• who had a history of heart failure,
• arrhythmia,
• cardiac catheterizations,
• angina,
• uncontrolled hypertension, and
• uncontrolled diabetes,
• patients with impaired liver function tests,
• patients who previously received anthracycline-containing regimens, and
• any cardiotoxic chemotherapy regimens, previous history of chest wall irradiation.
• Brian metastasis.

Trial design

111 participants in 2 patient groups

control group

Description:

55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen)

Treatment:

Drug: Ketotifen 1 MG

ketotifen group

Description:

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

Treatment:

Drug: Ketotifen 1 MG