H1-Switch: The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Drug: Cetirizine
Subjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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).]
The difference in the number of paclitaxel dosages until first HSR occurrence between the arms will be described.
- 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).]
The difference in the number of paclitaxel dosages until first HSR occurrence
Eligibility Criteria
Criteria
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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erasmus University Medical Center | Rotterdam | Zuid-Holland | Netherlands | 3015 GD |
Sponsors and Collaborators
- Erasmus Medical Center
Investigators
- Principal Investigator: Roelof van Leeuwen, PharmD, PhD, Erasmus Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- METC 2022-0007