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

NCT06039137 | Completed

• 1 other identifier: METC 2022-0007
• Study Type: observational
• Target: 395
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

Paclitaxel; Allergic reaction; HSR; Chemotherapy; Premedication; Cancer; Oncology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 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 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).

Study Arms (2)

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

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

Interventions

Cetirizine DRUG

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

Cetirizine group

Clemastine IV DRUG

Subjects were treated with paclitaxel premedication containing clemastine 2 mg IV

Clemastine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years;
• Planned treatment with regular paclitaxel-based chemotherapy for any indication and with any dose

You may not qualify if:

• Prior treatment with a paclitaxel-based regimen;
• Inability to orally ingest cetirizine

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus University Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Related Publications (1)

• Malmberg R, van Doorn L, Cox JM, Daloul A, Ettafahi H, Oomen-de Hoop E, Zietse M, Bos MEMM, Koch BCP, van Leeuwen RWF. Effect of Switching the Histamine-1 Receptor Antagonist Clemastine to Cetirizine in Paclitaxel Premedication Regimens: The H1-Switch Study. JCO Oncol Pract. 2024 Sep;20(9):1243-1251. doi: 10.1200/OP.24.00110. Epub 2024 Jun 7.

  PMID: 38848522 DERIVED

MeSH Terms

Conditions

Hypersensitivity; Neoplasms

Interventions

Cetirizine

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Roelof van Leeuwen, PharmD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: September 15, 2023
• Study Start: June 1, 2022
• Primary Completion: April 27, 2023
• Study Completion: October 31, 2023
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

NL (1)