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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

395 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-10-31

Brief Summary

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In this study the effect of substituting clemastine IV to cetirizine PO on the occurence of hypersensitivity reactions during paclitaxel chemotherapy will be investigated.

Detailed Description

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This is a single arm before-after study with a historic control cohort to evaluate the effect of a policy change (i.e. substitution of clemastine IV for cetirizine PO) regarding the premedication scheme on the incidence of HSR during paclitaxel based chemotherapy.

Conditions

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Solid Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Clemastine IV

Subjects were treated with paclitaxel premedication containing clemastine 2 mg IV

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Roelof W.F. van Leeuwen

Principal investigator

Responsibility Role 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

Site Status

Countries

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Netherlands

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.

Reference Type DERIVED
PMID: 38848522 (View on PubMed)

Other Identifiers

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METC 2022-0007

Identifier Type: -

Identifier Source: org_study_id

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