Ketotifen: as a Cardioprotective Agent… | Clinical Trial

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Iron Chelation Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Horus University

Damietta, Damiete Governonate, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketotifen 1 MG

Drug

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

Other names: placebo

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Horus University

Other

Registry information

Official study 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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Jun 17, 2020
Registry last updated: Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed