NCT06118710 Evaluation of the Omission of Dexamethasone in Premedication Regimens During Paclitaxel Treatment
| NCT ID | NCT06118710 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Erasmus Medical Center |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 500 participants in total. It began in 2024-06-25 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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 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.
Frequently Asked Questions
Who can join the NCT06118710 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06118710 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06118710 currently recruiting?
Yes, NCT06118710 is actively recruiting participants. Visit ClinicalTrials.gov or contact Erasmus Medical Center to inquire about joining.
Where is the NCT06118710 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT06118710 clinical trial?
NCT06118710 is sponsored by Erasmus Medical Center. The trial plans to enroll 500 participants.
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