Evaluating the need for dexamethasone during paclitaxel chemotherapy
Official title: Evaluation of the Omission of Dexamethasone in Premedication Regimens During Paclitaxel Treatment
Run by Erasmus Medical Center · NCT06118710 · Data updated 2026-11-12
This study is testing if skipping dexamethasone before paclitaxel chemotherapy is just as safe and effective for adults with solid tumors as using it.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rotterdam, South Holland) |
| Status | Recruiting |
| Started | June 25, 2024 |
| Main results expected | June 1, 2027 |
| Study ends | August 1, 2027 |
| Registry record updated | September 25, 2024 |
| Trial ID | NCT06118710 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a diagnosis of a solid tumor who are scheduled to receive paclitaxel-based chemotherapy.
✕Probably not a fit
Patients who have previously received paclitaxel treatment or have contraindications for its use will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized trial aims to determine if omitting dexamethasone from the premedication regimen during paclitaxel chemotherapy is as effective as the standard regimen that includes dexamethasone. The study will involve 500 adult patients with solid tumors and will assess the incidence of severe hypersensitivity reactions, as well as secondary endpoints such as quality of life and cost-effectiveness. The trial seeks to provide evidence on whether avoiding dexamethasone can improve patient outcomes and reduce side effects associated with its use.
Why it matters
Potential benefit: If successful, this study could lead to improved quality of life for patients undergoing paclitaxel treatment by reducing unnecessary medication and its associated side effects.
How similar studies have gone: While there have been studies suggesting lower doses of dexamethasone may be effective, this specific approach of omitting it entirely during paclitaxel treatment has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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 paclitaxel-based regimen; * An indication for paclitaxel in combination with moderately or highly emetogenic chemotherapy that mandates the use of dexamethasone as an anti-emetic medication (e.g., carboplatin AUC\>4); * Known hypersensitivity to paclitaxel, carboplatin, cetirizine, granisetron, ondansetron or excipients (e.g., benzyl alcohol); * Concomitant use of any systemic corticosteroid for any indication other than paclitaxel premedication; * Women with confirmed and ongoing pregnancy; * Already participating in an exercise trial.
Where it's running
-
Erasmus MC
Rotterdam, South Holland, Netherlands Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.