Clinical trial · Observational
Ketotifen: as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Iron Chelation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketotifen 1 MG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- control group
- description
- 55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen)
- interventionNames
- Drug: Ketotifen 1 MG
- label
- ketotifen group
- description
- 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
- interventionNames
- Drug: Ketotifen 1 MG
Primary outcomes (1)
- measure
- prophylaxis effect of Ketotifen on patient's hearts during the treatment of anthracyclines
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available