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Clinical trial

The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment: 'The H1-SWITCH Study'

ID
Name
METC 2022-0007
Description
In this study the effect of substituting clemastine IV to cetirizine PO on the occurence of hypersensitivity reactions during paclitaxel chemotherapy will be investigated.
Trial arms
Trial start
2022-06-01
Estimated PCD
2023-04-27
Trial end
2023-10-31
Status
Completed
Treatment
Cetirizine
Subjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine
Arms:
Cetirizine group
Size
395
Primary endpoint
Clinically relevant hypersensitivity reactions
During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).
Eligibility criteria
Inclusion Criteria: * Age ≥ 18 years; * Planned treatment with regular paclitaxel-based chemotherapy for any indication and with any dose Exclusion Criteria: * Prior treatment with a paclitaxel-based regimen; * Inability to orally ingest cetirizine
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 395, 'type': 'ACTUAL'}}
Updated at
2024-02-20

1 organization

1 product

1 indication

Organization
Erasmus Medical Center
Product
Cetirizine
Indication
Solid Tumor