Evaluation of the Omission of Dexamethasone in Premedication Regimens During Paclitaxel Treatment
Recruiting
Phase 4
Interventional Study
Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 500 (estimated)
- Sponsor
- Erasmus Medical Center · Other
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About This Trial
This prospective multicenter randomized non-inferiority trial aims to assess whether omitting dexamethasone from the premedication regimen during paclitaxel-based chemotherapy is non-inferior to the standard of care regimen that includes dexamethasone, based on the incidence of clinically relevant hypersensitivity reactions (HSRs) of grade ≥3 as per CTCAE v5.0. With a study population of 500 adult…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years;
* Diagnosis of a solid tumor with planned treatment with paclitaxel-based chemotherapy for any indication and with any dose.
* Mastery of Dutch language
* Able and willing to give written informed consent.
Exclusion Criteria:
* Prior treatment with a paclitaxe…
Contacts
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