Solid Tumor
Conditions
Keywords
Paclitaxel, Allergic reaction, HSR, Chemotherapy, Premedication, Cancer, Oncology
Brief summary
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
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.
Interventions
DRUGCetirizine
Subjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine
DRUGClemastine IV
Subjects were treated with paclitaxel premedication containing clemastine 2 mg IV
Sponsors
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically relevant hypersensitivity reactions | 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). | Hypersensitivity reactions grade 3 or higher according to CTCAE v4.03 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypersensitivity reactions | 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). | Hypersensitivity reactions any grade according to CTCAE v4.03 |
| The difference in the number of paclitaxel dosages until first occurrence of hypersensitivity reactions | 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 the occurrence of hypersensitivity reactions between the arms will be described. |
| The cumulative dose of paclitaxel (mg/m2) administered prior to the moment 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). | The cumulative dose of paclitaxel (mg/m2) administered prior to the moment of occurrence of hypersensitivity reaction |
Countries
Netherlands
Outcome results
None listed