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

June 15, 2020 updated by: hosny ahmed elewa, Horus University

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

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%).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Damiete Governonate
      • Damietta, Damiete Governonate, Egypt, 12345
        • Horus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
control group
55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen)
Drug: Ketotifen 1 MG
Ketotifen is added to patients on anthracycline-containing chemotherapy for 6 months
Other Names:
  • placebo
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
Drug: Ketotifen 1 MG
Ketotifen is added to patients on anthracycline-containing chemotherapy for 6 months
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
prophylaxis effect of Ketotifen on patient's hearts during the treatment of anthracyclines
Time Frame: 6 months
the serum levels of LDH, CK-MB, troponin I, TIBC, ferritin, anti-cardiolipin IgG, and, iron were done
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Horus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1890-1-2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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