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

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ClinicalTrials.gov Identifier: NCT04435028
Recruitment Status : Completed
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
hosny ahmed elewa, Horus University

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%).

Condition or disease Intervention/treatment
Breast Cancer Iron Chelation Drug: Ketotifen 1 MG

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.

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Study Type : Observational
Actual Enrollment : 111 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : January 14, 2019
Actual Primary Completion Date : August 13, 2019
Actual Study Completion Date : August 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer Iron

Group/Cohort Intervention/treatment
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 Name: 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 Name: placebo




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   as the study was on breast cancer female patients
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435028


Locations
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Egypt
Horus University
Damietta, Damiete Governonate, Egypt, 12345
Sponsors and Collaborators
Horus University
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Responsible Party: hosny ahmed elewa, head of pharmacy practice department, Horus University
ClinicalTrials.gov Identifier: NCT04435028    
Other Study ID Numbers: 1890-1-2019
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Ketotifen
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents