The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment (H1-Switch)

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Erasmus University

Status

Completed

Conditions

Solid Tumor

Treatments

Drug: Cetirizine

Study type

Observational

Funder types

Other

Identifiers

NCT06039137
METC 2022-0007

Details and patient eligibility

About

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

Full description

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.

Enrollment

395 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

395 participants in 2 patient groups

Clemastine group
Description:
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
Cetirizine group
Description:
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
Treatment:
Drug: Cetirizine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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