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

• Sponsor: Horus University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04435028
• Collaborator: (none)
• Enrollment: 111
• Location: 1
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 16

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Jan 14, 2019
• Actual Primary Completion Date: Aug 13, 2019
• Actual Study Completion Date: Aug 13, 2019

Arms and Interventions

Arm	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 Names: 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 Names: placebo

Outcome Measures

Primary Outcome Measures

1. prophylaxis effect of Ketotifen on patient's hearts during the treatment of anthracyclines [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Horus University	Damietta	Damiete Governonate	Egypt	12345

Sponsors and Collaborators

• Horus University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jun 17, 2020
• Last Update Posted: Jun 17, 2020
• Last Verified: Jun 1, 2020

• 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: Breast Neoplasms; Ketotifen

Study Results

No Results Posted as of Jun 17, 2020