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

Trial status: Authorised 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. 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 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.

Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 500 participants