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

Solid Tumor Clinical Trial

— H1-Switch  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06039137
• Other study ID #: METC 2022-0007
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: October 31, 2023
• Est. primary completion date: April 27, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
Netherlands	Erasmus University Medical Center	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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.	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	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).