Evaluation of the Omission of Dexamethasone in Premedication Regimens During Paclitaxel Treatment

• Status: Not yet recruiting
• Trial end date: 2027-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Treatments: Dexamethasone; Histamine Antagonists; Histamine H1 Antagonists

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.