Actively Recruiting
Evaluation of the Omission of Dexamethasone in Premedication Regimens During Paclitaxel Treatment
Led by Erasmus Medical Center · Updated on 2024-09-25
500
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of the Omission of Dexamethasone in Premedication Regimens During Paclitaxel Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of a solid tumor with planned paclitaxel-based chemotherapy for any indication and dose
- Mastery of Dutch language
- Able and willing to provide written informed consent
You will not qualify if you...
- Prior treatment with a paclitaxel-based regimen
- Need for dexamethasone as anti-emetic with moderately or highly emetogenic chemotherapy (e.g., carboplatin AUC>4)
- Known hypersensitivity to paclitaxel, carboplatin, cetirizine, granisetron, ondansetron, or related excipients
- Use of systemic corticosteroids for any indication other than paclitaxel premedication
- Confirmed and ongoing pregnancy
- Currently participating in an exercise trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CN
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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