Skip to main content
OpenTrials
Completed

NCT Number: NCT06039137

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Solid Tumor Hypersensitivity Immune System Diseases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus University Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetirizine

Drug

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

Clemastine IV

Drug

Subjects were treated with paclitaxel premedication containing clemastine 2 mg IV

Primary outcomes

  1. Clinically relevant hypersensitivity reactions

    Time frame: 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 outcomes

  1. Hypersensitivity reactions

    Time frame: 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

  2. The difference in the number of paclitaxel dosages until first occurrence of hypersensitivity reactions

    Time frame: 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.

  3. The cumulative dose of paclitaxel (mg/m2) administered prior to the moment of hypersensitivity reaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: H1-Switch

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 15, 2023
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.