Clinical trial · Interventional
Evaluation of the Omission of Dexamethasone in Premedication Regimens During Paclitaxel Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 patients with solid tumors, the trial will also investigate secondary endpoints including the severity and incidence of HSRs of any grade, the number of paclitaxel administrations until the first HSR, the impact on patients' quality of life, adverse events related to dexamethasone, and the cost-effectiveness of the two premedication regimens from healthcare and societal perspectives.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| H1 Antihistaminics | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental premedication regimen
- description
- Local standard of care premedication regimen with an Histamine-1 antagonist (e.g. clemastine or cetirizine) without dexamethasone
- interventionNames
- Drug: H1 Antihistaminics
- type
- ACTIVE_COMPARATOR
- label
- Local standard of care premedication regimen
- description
- Local standard of care premedication regimen with an Histamine-1 antagonist (e.g. clemastine or cetirizine) with dexamethasone
- interventionNames
- Drug: Dexamethasone
- Drug: H1 Antihistaminics
Primary outcomes (1)
- measure
- The primary outcome is the percentage of patients who experience a clinically relevant HSR (CTCAE grade ≥3) during paclitaxel infusion (Yes/No), determined prospectively by the oncology medical staff (e.g. oncologist).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDZietse M, Aalders LC, Spierings LEAMM, De Rouw N, Dercksen W, Dalm VASH, Oomen-de Hoop E, Thielen FW, Koch BCP, Mathijssen RHJ, van Doorn L, Leeuwen RWFV. Omission of dexamethasone in paclitaxel premedication regimens: protocol of the multicentre, randomised, non-inferiority DEXASTOP trial. BMJ Open. 2025 Apr 25;15(4):e102770. doi: 10.1136/bmjopen-2025-102770. PMID 40280620