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

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

In this study the effect of substituting clemastine IV to cetirizine PO on the occurence of hypersensitivity reactions during paclitaxel chemotherapy will be investigated.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Cetirizine; Drug: Clemastine IV

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 Type: Observational
• Enrollment (Actual): 395

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Erasmus University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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	Drug: Clemastine IV; Subjects were treated with paclitaxel premedication containing 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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	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).

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Roelof van Leeuwen, PharmD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Chemotherapy; Oncology; Paclitaxel; Premedication; Allergic reaction; HSR
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Cetirizine; Clemastine
• Other Study ID Numbers: METC 2022-0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No