Evaluation of the omission of dexamethasone in premedication regimens during paclitaxel treatment

Conditions

Solid tumors

Brief summary

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).

Detailed description

The incidence of the HSRs (all grades) as defined by (CTCAE v.5.0);, The severity (grades) of all HSRs as defined by (CTCAE v.5.0);, 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 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 total cost of treatment of both premedication regimens from a healthcare and societal perspective.

Related papers

No related papers found yet.

Interventions

DRUGDexamethasone 4 mg tablets

DRUGDexamethasone Phosphate 4 mg/ml Solution for Injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
The incidence of the HSRs (all grades) as defined by (CTCAE v.5.0);, The severity (grades) of all HSRs as defined by (CTCAE v.5.0);, 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 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 total cost of treatment of both premedication regimens from a healthcare and societal perspective.	—

Measure

Time frame

The incidence of the HSRs (all grades) as defined by (CTCAE v.5.0);, The severity (grades) of all HSRs as defined by (CTCAE v.5.0);, 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 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 total cost of treatment of both premedication regimens from a healthcare and societal perspective.

—

Countries

Netherlands

Outcome results

None listed