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

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