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

Erasmus Medical Center395 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

395

Conditions

Solid Tumor

Interventions

CetirizineDRUG

Subjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine

Clemastine IVDRUG

Subjects were treated with paclitaxel premedication containing clemastine 2 mg IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Erasmus University Medical Center

Rotterdam, South Holland, Netherlands

Outcomes

Primary Outcomes

Clinically relevant hypersensitivity reactions

Hypersensitivity reactions grade 3 or higher according to CTCAE v4.03

Time frame: 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).

Secondary Outcomes

Hypersensitivity reactions

Hypersensitivity reactions any grade according to CTCAE v4.03

Time frame: 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).

The difference in the number of paclitaxel dosages until first occurrence of hypersensitivity reactions

The difference in the number of paclitaxel dosages until first the occurrence of hypersensitivity reactions between the arms will be described.

Time frame: 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).

The cumulative dose of paclitaxel (mg/m2) administered prior to the moment of hypersensitivity reaction

The cumulative dose of paclitaxel (mg/m2) administered prior to the moment of occurrence of hypersensitivity reaction

Time frame: 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).

Data from ClinicalTrials.gov

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