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

Completed

• Conditions: Solid Tumor
• Interventions: Drug: Clemastine IV; Drug: Cetirizine

• Registration Number: NCT06039137
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-04-27
• Study First Submitted: 2023-08-11
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Study Completion: 2023-10-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clemastine group	Clemastine IV	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	Cetirizine	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Erasmus University Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands