Status:
RECRUITING
Evaluation of the Omission of Dexamethasone in Premedication Regimens During Paclitaxel Treatment
Lead Sponsor:
Erasmus Medical Center
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 s...
Detailed Description
Rationale Dexamethasone is administered alongside a H1-antagonist (e.g. cetirizine) to prevent hypersensitivity reactions (HSRs) during paclitaxel chemotherapy. However, the rationale seems limited an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06118710
Start Date
June 25 2024
End Date
August 1 2027
Last Update
September 25 2024
Active Locations (1)
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1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CN