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

NCT ID: NCT04435028

Last Updated: 2020-06-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 111 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2019-08-13

Brief Summary

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%).

Detailed 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.

Conditions

Breast Cancer; Iron Chelation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

control group

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

Ketotifen 1 MG

Intervention Type: DRUG

Ketotifen is added to patients on anthracycline-containing chemotherapy for 6 months

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

Ketotifen 1 MG

Intervention Type: DRUG

Ketotifen is added to patients on anthracycline-containing chemotherapy for 6 months

Interventions

Ketotifen 1 MG

Ketotifen is added to patients on anthracycline-containing chemotherapy for 6 months

Intervention Type: DRUG

Other Intervention Names

placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Horus University

OTHER

Sponsor Role: lead

Responsible Party

hosny ahmed elewa

head of pharmacy practice department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Horus University

Damietta, Damiete Governonate, Egypt

Countries

Egypt

Other Identifiers

1890-1-2019

Identifier Type: -

Identifier Source: org_study_id