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

NCT06118710 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-09-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dexamethasone

Dexamethasone prior to paclitaxel infusion according to local care standards.

DRUG

H1 Antihistaminics

Clemastine or Cetirizine prior to paclitaxel infusion according to local care standards

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2027-06-01
Completion
2027-08-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06118710 on ClinicalTrials.gov