Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06118710
Other study ID # EU_CT 2023-507481-43-00
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2024
Est. completion date August 1, 2027

Study information

Verified date November 2023
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Rationale Dexamethasone is administered alongside a H1-antagonist (e.g. cetirizine) to prevent hypersensitivity reactions (HSRs) during paclitaxel chemotherapy. However, the rationale seems limited and several studies have demonstrated no increase in HRSs after discontinuation of dexamethasone after the second paclitaxel administration. In addition, two studies have demonstrated the feasibility of lower doses of dexamethasone in paclitaxel premedication regimens. Furthermore, there seems to be no statistically significant association between the administration route (Intravenous (IV) or oral) or dose of dexamethasone and the HSR rate. Dexamethasone may lead to serious side effects such as hyperglycemia, immune suppression, mood disturbances, sleeping disorders, and weight gain, thereby negatively affecting the patient's health-related quality of life (HRQoL). Discontinuing dexamethasone might result in improved HRQoL, decreased healthcare costs, and more efficient premedication regimens. However, no head-to-head studies on dexamethasone's added value in preventing paclitaxel-induced HSRs have been performed. Therefore, the aim of our study is to demonstrate that the premedication regimen without dexamethasone is non-inferior to the standard of care premedication regimen with dexamethasone, based on the incidence of paclitaxel-induced HSRs (Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade ≥3). Objective The primary objective is to evaluate the incidence of clinically relevant HSRs (grade ≥3 as per Common Terminology Criteria for Adverse Events; CTCAE version 5.0) during paclitaxel-based chemotherapy with a standard of care premedication regimen with dexamethasone compared to an experimental premedication regimen without dexamethasone. Secondary objectives are: To determine the incidence and severity of HSRs (any grade) during paclitaxel-based chemotherapy with a standard of care premedication regimen with dexamethasone compared to an experimental premedication regimen without dexamethasone; To determine the number of paclitaxel administrations and cumulative dose until the first HSR occurrence (any grade); To determine the effect of dexamethasone omission on the patient's quality of life; To determine the incidence and severity of adverse events related to dexamethasone; To determine the cost-effectiveness of the premedication regimens with and without dexamethasone from a healthcare and societal perspective. Main trial endpoints The primary outcome will be 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). Secondary trial endpoints Secondary outcomes are: The severity of the HSR grades as defined by (CTCAE v.5.0); The incidence of the HSRs (all grades) as defined by (CTCAE v.5.0); The percentage (%) of patients that can be rechallenged (conform standard of care) after the occurrence of an HSR with or without dexamethasone; The number of paclitaxel administrations and cumulative dose (mg) until the first HSR occurrence; The incidence and severity of adverse events related to dexamethasone measured through the validated Dexamethasone Symptom Questionnaire (DSQ)(21); The patient quality of life measured using the EuroQol-5 dimensions-5 levels (EQ-5D-5L) and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) scorings tools); The costs of the paclitaxel premedication regimen with and without dexamethasone from a healthcare and societal perspective. Trial design This is a prospective, multicenter, randomized, non-inferiority trial. Trial population In total, 500 patients (≥18 yo) with solid tumors (any indication) for whom paclitaxel-based chemotherapy is considered standard treatment will be included. Interventions Eligible patients will be randomized 1:1 to receive either the local standard of care premedication regimen with dexamethasone or the experimental premedication regimen without dexamethasone during five administrations of paclitaxel. Patients will start with paclitaxel treatment on the physicians recommended dose as standard of care.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date August 1, 2027
Est. primary completion date January 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
Dexamethasone prior to paclitaxel infusion according to local care standards.
H1 Antihistaminics
Clemastine or Cetirizine prior to paclitaxel infusion according to local care standards

Locations

Country Name City State
Netherlands Erasmus MC Rotterdam Zuid-Holland

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The severity of the HSR grades as defined by (CTCAE v.5.0); 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
Secondary The incidence of the HSRs (all grades) as defined by (CTCAE v.5.0); 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
Secondary The percentage (%) of patients that can be rechallenged (according to standard of care procedures) after the occurrence of an HSR with or without dexamethasone; 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
Secondary The incidence and severity of adverse events related to dexamethasone measured through the validated Dexamethasone Symptom Questionnaire (DSQ) 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
Secondary The patient quality of life measured using the EuroQol-5 dimensions-5 levels (EQ-5D-5L) scorings tools. The patient quality of life measured using the EuroQol-5 dimensions-5 levels (EQ-5D-5L) and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) scorings tools) Throughout the entire duration of the study, spanning five cycles (each cycle is 7 days) of paclitaxel treatment
Secondary The patient quality of life measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) scorings tools. The patient quality of life measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) scorings tools. Throughout the entire duration of the study, spanning five cycles (each cycle is 7 days) of paclitaxel treatment
Secondary • The total cost of treatment of both premedication regimens from a healthcare and societal perspective. • The total cost of treatment of both premedication regimens from a healthcare and societal perspective. Throughout the entire duration of the study, spanning five cycles (each cycle is 7 days) of paclitaxel treatment
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients