The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment
NCT ID: NCT06039137
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
395 participants
OBSERVATIONAL
2022-06-01
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Clemastine group
Subjects receiving standard of care treatment with paclitaxel either as monotherapy or as part of a combination for any standard of care oncologic indication. Subjects received a paclitaxel premedication regimen containing dexamethasone 10 mg IV and clemastine 2 mg IV
Clemastine IV
Subjects were treated with paclitaxel premedication containing clemastine 2 mg IV
Cetirizine group
Subjects receiving standard of care treatment with paclitaxel either as monotherapy or as part of a combination for any standard of care oncologic indication. Subjects received a paclitaxel premedication regimen containing dexamethasone 10 mg IV and cetirizine 10 mg PO
Cetirizine
Subjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine
Interventions
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Cetirizine
Subjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine
Clemastine IV
Subjects were treated with paclitaxel premedication containing clemastine 2 mg IV
Eligibility Criteria
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Inclusion Criteria
* Planned treatment with regular paclitaxel-based chemotherapy for any indication and with any dose
Exclusion Criteria
* Inability to orally ingest cetirizine
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Roelof W.F. van Leeuwen
Principal investigator
Principal Investigators
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Roelof van Leeuwen, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus University Medical Center
Rotterdam, South Holland, Netherlands
Countries
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References
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Malmberg R, van Doorn L, Cox JM, Daloul A, Ettafahi H, Oomen-de Hoop E, Zietse M, Bos MEMM, Koch BCP, van Leeuwen RWF. Effect of Switching the Histamine-1 Receptor Antagonist Clemastine to Cetirizine in Paclitaxel Premedication Regimens: The H1-Switch Study. JCO Oncol Pract. 2024 Sep;20(9):1243-1251. doi: 10.1200/OP.24.00110. Epub 2024 Jun 7.
Other Identifiers
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METC 2022-0007
Identifier Type: -
Identifier Source: org_study_id
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