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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetirizine | Drug | Subjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine |
|
| 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). |
| 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 occurrence of hypersensitivity reactions |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with solid tumors for whom paclitaxel-based chemotherapy is considered standard treatment will be eligible for this trial. Patients will be included from the outpatient population of the Erasmus MC in Rotterdam.
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| Name | Affiliation | Role |
|---|---|---|
| Roelof van Leeuwen, PharmD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus University Medical Center | Rotterdam | South Holland | 3015 GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38848522 | Derived | 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. |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Clemastine IV | Drug | Subjects were treated with paclitaxel premedication containing clemastine 2 mg IV |
|
The difference in the number of paclitaxel dosages until first the occurrence of hypersensitivity reactions 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 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 | 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). |