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

Breast Cancer Clinical Trial

Official title:

Ketotifen: Novel Use as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy as Well as the Potential Beneficial Effects of Ketotifen in the Hypothetical Management of COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04435028
• Other study ID #: 1890-1-2019
• Status: Completed
• Start date: January 14, 2019
• Est. completion date: August 13, 2019

Study information

• Verified date: June 2020
• Source: Horus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: August 13, 2019
• Est. primary completion date: August 13, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Iron Chelation

Intervention

Drug:
• Ketotifen 1 MG
Ketotifen is added to patients on anthracycline-containing chemotherapy for 6 months

Locations

Country	Name	City	State
Egypt	Horus University	Damietta	Damiete Governonate

Sponsors (1)

Lead Sponsor	Collaborator
Horus University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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