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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

Tracking Information
First Submitted Date June 15, 2020
First Posted Date June 17, 2020
Last Update Posted Date June 17, 2020
Actual Study Start Date January 14, 2019
Actual Primary Completion Date August 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ketotifen: as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy
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
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%).
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 Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Breast Cancer
  • Iron Chelation
Intervention Drug: Ketotifen 1 MG
Ketotifen is added to patients on anthracycline-containing chemotherapy for 6 months
Other Name: placebo
Study Groups/Cohorts
  • control group
    55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen)
    Intervention: Drug: Ketotifen 1 MG
  • 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
    Intervention: Drug: Ketotifen 1 MG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 15, 2020)
111
Original Actual Enrollment Same as current
Actual Study Completion Date August 13, 2019
Actual Primary Completion Date August 13, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: as the study was on breast cancer female patients
Ages 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT04435028
Other Study ID Numbers 1890-1-2019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party hosny ahmed elewa, Horus University
Study Sponsor Horus University
Collaborators Not Provided
Investigators Not Provided
PRS Account Horus University
Verification Date June 2020