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

Study Overview
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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.

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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Cetirizine


Participation Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clemastine group<br>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<br>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 | Drug: Cetirizine<br>* Subjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically relevant hypersensitivity reactions | Hypersensitivity reactions grade 3 or higher according to CTCAE v4.03 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypersensitivity reactions | Hypersensitivity reactions any grade according to CTCAE v4.03 | 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 HSR occurrence | The difference in the number of paclitaxel dosages until first HSR occurrence between the arms will be described. | 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 HSR occurrence | The difference in the number of paclitaxel dosages until first HSR occurrence | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paclitaxel, Allergic reaction, HSR, Chemotherapy, Premedication, Cancer, Oncology