Solid TumorH1-SwitchNCT06039137
The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment
An observational study of Solid Tumor, run by Erasmus Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Cetirizine and Clemastine IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 395 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2022to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years;
- Planned treatment with regular paclitaxel-based chemotherapy for any indication and with any dose
Who cannot join
- Prior treatment with a paclitaxel-based regimen;
- Inability to orally ingest cetirizine
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus University Medical Center
Rotterdam, South Holland, 3015 GD
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- Cetirizine, Clemastine IV
- Keywords
- Paclitaxel, Allergic reaction, HSR, Chemotherapy, Premedication, Cancer, Oncology
- Medical subject headings
- Hypersensitivity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetirizineDrug
Subjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine
Clemastine IVDrug
Subjects were treated with paclitaxel premedication containing clemastine 2 mg IV
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Cetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically relevant hypersensitivity reactions
Hypersensitivity reactions grade 3 or higher according to CTCAE v4.03
Measured: 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
Hypersensitivity reactions any grade according to CTCAE v4.03
Measured: 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.
Measured: 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
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Jun 2022
- Primary completion27 Apr 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roelof W.F. van Leeuwen, Erasmus Medical Center
- Investigators
- Roelof van Leeuwen, PharmD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039137
- Sponsor's protocol ID
- METC 2022-0007
- Acronym
- H1-Switch
- Status last verified
- Sep 2024
- First submitted
- 11 Aug 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38848522
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment: 'The H1-SWITCH Study'
- ClinicalTrials.gov ID
- NCT06039137
- Acronym / sponsor ID
- H1-Switch / METC 2022-0007
- Conditions
- Solid Tumor
- Keywords
- Paclitaxel, Allergic reaction, HSR, Chemotherapy, Premedication, Cancer, Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clemastine group | – | Drug: Clemastine IVSubjects 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 | – | Drug: CetirizineSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age ≥ 18 years;
- Planned treatment with regular paclitaxel-based chemotherapy for any indication and with any dose
Key exclusion criteria (2 listed)
- Prior treatment with a paclitaxel-based regimen;
- Inability to orally ingest cetirizine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetirizineSubjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine | Drug | Cetirizine group |
| Clemastine IVSubjects were treated with paclitaxel premedication containing clemastine 2 mg IV | Drug | Clemastine group |
Primary outcome
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
3 secondary outcomes
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 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 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Derived from this study: PubMed 38848522Malmberg 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roelof van Leeuwen, PharmD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06039137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.