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

NCT06118710 | Recruiting Phase 4

• 1 other identifier: EU_CT 2023-507481-43-00
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the percentage of patients who experience a clinically relevant HSR (CTCAE grade ≥3) during paclitaxel infusion (Yes/No), determined prospectively by the oncology medical staff (e.g. oncologist).

  The primary outcome is the percentage of patients who experience a clinically relevant HSR (CTCAE grade ≥3) during paclitaxel infusion (Yes/No), determined prospectively by the oncology medical staff (e.g. oncologist).

  Throughout the entire duration of the study, spanning five cycles of paclitaxel treatment

Secondary Outcomes (7)

• The severity of the HSR grades as defined by (CTCAE v.5.0);

  Throughout the entire duration of the study, spanning five cycles (each cycle is 7 days) of paclitaxel treatment

• The incidence of the HSRs (all grades) as defined by (CTCAE v.5.0);

  Throughout the entire duration of the study, spanning five cycles (each cycle is 7 days) of paclitaxel treatment

• The percentage (%) of patients that can be rechallenged (according to standard of care procedures) after the occurrence of an HSR with or without dexamethasone;

  Throughout the entire duration of the study, spanning five cycles (each cycle is 7 days) of paclitaxel treatment

• The incidence and severity of adverse events related to dexamethasone measured through the validated Dexamethasone Symptom Questionnaire (DSQ)

  Throughout the entire duration of the study, spanning five cycles (each cycle is 7 days) of paclitaxel treatment

• The patient quality of life measured using the EuroQol-5 dimensions-5 levels (EQ-5D-5L) scorings tools.

  Throughout the entire duration of the study, spanning five cycles (each cycle is 7 days) of paclitaxel treatment

Study Arms (2)

Experimental premedication regimen

EXPERIMENTAL

Local standard of care premedication regimen with an Histamine-1 antagonist (e.g. clemastine or cetirizine) without dexamethasone

Drug: H1 Antihistaminics

Local standard of care premedication regimen

ACTIVE COMPARATOR

Local standard of care premedication regimen with an Histamine-1 antagonist (e.g. clemastine or cetirizine) with dexamethasone

Drug: Dexamethasone; Drug: H1 Antihistaminics

Interventions

Dexamethasone DRUG

Dexamethasone prior to paclitaxel infusion according to local care standards.

Local standard of care premedication regimen

H1 Antihistaminics DRUG

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

Experimental premedication regimen; Local standard of care premedication regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 CN, Netherlands

RECRUITING

Related Publications (1)

• Zietse M, Aalders LC, Spierings LEAMM, De Rouw N, Dercksen W, Dalm VASH, Oomen-de Hoop E, Thielen FW, Koch BCP, Mathijssen RHJ, van Doorn L, Leeuwen RWFV. Omission of dexamethasone in paclitaxel premedication regimens: protocol of the multicentre, randomised, non-inferiority DEXASTOP trial. BMJ Open. 2025 Apr 25;15(4):e102770. doi: 10.1136/bmjopen-2025-102770.

  PMID: 40280620 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Dexamethasone; Histamine H1 Antagonists

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, multicenter, randomized, non-inferiority trial.

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 7, 2023
• Study Start: June 25, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)