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NCT04435028
Ketotifen: as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy
trial testing Ketotifen 1 MG in Breast Cancer in 111 participants. Completed in 13 August 2019.
13 August 2019
Quick facts
| Lead sponsor | Horus University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 111 |
| Start date | 14 January 2019 |
| Primary completion | 13 August 2019 |
| Estimated completion | 13 August 2019 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Ketotifen 1 MG — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Iron Chelation — all drugs for Iron Chelation →
Sponsor
Horus University
Who can join
Adults 30 to 60, female only, with Breast Cancer or Iron Chelation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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%).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Transferrin receptor in primary and metastatic breast cancer: Evaluation of expression and experimental modulation to improve molecular targeting.
Fontana F, Esser AK, Egbulefu C, Karmakar P, et al · · 2023 · cited 11× · PMID 38117806 · DOI 10.1371/journal.pone.0293700 -
The identification of ketotifen as a novel cardioprotective agent in patients undergoing anthracyclines chemotherapy
elewa h, elberay N, Keshk W, Abulkhair H. · · 2021 · DOI 10.22541/au.161278751.19764242/v1 -
Novel use of Ketotifen as a cardio-protective agent in patients undergoing anthracycline chemotherapy
elewa h, elberay N, elsharif a, Keshk W, et al · · 2021 · DOI 10.22541/au.160992639.92887113/v1
Verify or expand the search:
- PubMed search for NCT04435028
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04435028 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Horus University
- Last refreshed: 17 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04435028.
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