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

NCT04435028 | Completed DMC FDA Drug

• 1 other identifier: 1890-1-2019
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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%).

Conditions

Breast Cancer; Iron Chelation

Outcome Measures

Primary Outcomes (1)

• prophylaxis effect of Ketotifen on patient's hearts during the treatment of anthracyclines

  the serum levels of LDH, CK-MB, troponin I, TIBC, ferritin, anti-cardiolipin IgG, and, iron were done

  6 months

Study Arms (2)

control group

55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen)

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

Drug: Ketotifen 1 MG

Interventions

Ketotifen 1 MG DRUG

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

Also known as: placebo

control group; ketotifen group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: as the study was on breast cancer female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

Horus University

Damietta, Damiete Governonate, 12345, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ketotifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of pharmacy practice department

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: January 14, 2019
• Primary Completion: August 13, 2019
• Study Completion: August 13, 2019
• Last Updated: June 17, 2020

Record last verified: 2020-06

Locations

EG (1)