Evaluation of the omission of dexamethasone in premedication regimens during paclitaxel treatment
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- 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).
研究概览
简要总结
The primary objective of this study 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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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, 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.
结局指标
主要结局
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).
次要结局
- 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.
研究者
Department of Hospital Pharmacy
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)