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

Launched by ERASMUS MEDICAL CENTER · Nov 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether it is safe and effective to skip a medication called dexamethasone before receiving paclitaxel chemotherapy for cancer treatment. Dexamethasone is typically given to help prevent allergic reactions during treatment. The trial will compare the standard approach that includes dexamethasone to a new approach that omits it, focusing on whether patients experience severe allergic reactions. Researchers will also look at other factors, such as the overall quality of life for patients and the costs associated with each treatment method.

To participate in this trial, you need to be at least 18 years old and have a solid tumor that requires treatment with paclitaxel. You should be able to speak and understand Dutch and be willing to provide written consent. However, if you have previously received paclitaxel treatment, are pregnant, or have certain allergies or health conditions, you would not be eligible to join. If you participate, you can expect regular check-ups and to provide information about your health throughout the study. This trial is currently recruiting participants, and it aims to help improve cancer treatment options for patients in the future.

Gender

ALL

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.