Ketotifen: as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy
Condition: Breast Cancer; Iron Chelation
MeSH terms: Breast Neoplasms
Study type: Observational

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.
    

Intervention name(s): Ketotifen 1 MG
Intervention type(s): Drug
Intervention description(s): Ketotifen is added to patients on anthracycline-containing chemotherapy for 6 months
Other intervention name(s): placebo
Intervention MeSH terms: Ketotifen
Observational model: Other
Time perspective: Prospective
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