Étude Pilote DEXEL-RH: Comparaison de Deux schémas Posologiques de DEXaméthasone en prévention Des Réactions d'Hypersensibilité au paclitaXEL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quality of life assessed by the self-administered quality of life core questionnaire (QLQ-C30) version 3.0 from the European Organisation for Research and Treatment in Cancer (EORTC)
研究概览
简要总结
This is a prospective, randomized, unicentric, two-arm, parallel, controlled, and double blind pilot study.
The purpose of this pilot study is to assess the feasibility of a trial designed to compare the quality of life of patients taking dexamethasone in two different ways to prevent hypersensitivity reactions to paclitaxel.
Dexamethasone given intravenously (IV) 30 minutes before paclitaxel could improve quality of life, could adequately prevent hypersensitivity reactions to paclitaxel and could reduce adverse effects compared to dexamethasone given orally 12 hours and 6 hours before paclitaxel.
详细描述
Primary objective:
To assess the feasibility of a randomized, parallel, two-arm, controlled and double blind trial designed to compare the quality of life of patients taking dexamethasone 20 mg IV 30 minutes before paclitaxel with those taking a standard dose of dexamethasone, 20 mg orally 12 hours and 6 hours before paclitaxel, in patients taking paclitaxel every two to three weeks for a minimum of two cycles in order to estimate a sample size.
Secondary objectives:
Between the two study groups, to compare:
- Quality of life during the first two cycles of chemotherapy;
- Efficacy of dexamethasone in preventing acute hypersensitivity reactions to paclitaxel in the first two cycles of chemotherapy;
- Adverse effects associated with dexamethasone on a daily basis during the first seven days of the first two cycles of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient treated at the outpatient clinic or admitted to the oncology unit of Notre-Dame Hospital between February 4, 2013 and July 19, 2013;
- •Patient diagnosed with cancer;
- •Patient starting a chemotherapy containing paclitaxel every two to three weeks for a minimum of two cycles;
- •Patient aged 18 years and over;
- •Patient able to give free and informed consent and who agrees to participate by signing the consent form;
- •Patient able to complete the questionnaire on quality of life EORTC QLQ-C30 and the personal logbook.
排除标准
- •Patient unable to speak English or French;
- •Patient who has previously received paclitaxel;
- •Patient receiving a prescription of paclitaxel bound to albumin;
- •Patient is currently under treatment with systemic corticosteroids or has received systemic corticosteroids during the last week;
- •Patient in another research protocol evaluating a different chemotherapy regimen;
- •Patient who had an allergic reaction to taxanes;
- •Patient with severe intolerance to lactose;
- •Patient with an allergy or a severe intolerance to products containing castor oil (eg.: cyclosporine and vitamin K).
研究组 & 干预措施
Group A (dexamethasone per os)
- Dexamethasone 20 mg per os 12 hours and 6 hours before paclitaxel (form: opaque white capsules)
- Matching placebo for dexamethasone IV (NaCl 0,9%) 30 minutes before paclitaxel
干预措施: Matching placebo for dexamethasone IV (Drug)
Group A (dexamethasone per os)
- Dexamethasone 20 mg per os 12 hours and 6 hours before paclitaxel (form: opaque white capsules)
- Matching placebo for dexamethasone IV (NaCl 0,9%) 30 minutes before paclitaxel
干预措施: Dexamethasone per os (Drug)
Group B (dexamethasone IV)
- Dexamethasone 20 mg IV 30 minutes before paclitaxel
- Matching placebo for dexamethasone per os (lactose capsule) 12 hours and 6 hours before paclitaxel (form: opaque white capsules)
干预措施: Dexamethasone IV (Drug)
Group B (dexamethasone IV)
- Dexamethasone 20 mg IV 30 minutes before paclitaxel
- Matching placebo for dexamethasone per os (lactose capsule) 12 hours and 6 hours before paclitaxel (form: opaque white capsules)
干预措施: Matching placebo for dexamethasone per os (Drug)
结局指标
主要结局
Quality of life assessed by the self-administered quality of life core questionnaire (QLQ-C30) version 3.0 from the European Organisation for Research and Treatment in Cancer (EORTC)
时间窗: Day before chemotherapy (Day 0) of the first cycle of chemotherapy
Comparison of the scores according to the EORTC Scoring Manual.
Quality of life assessed by the self-administered questionnaire QLQ-C30 version 3.0 from the EORTC
时间窗: Day 6 of the second cycle of chemotherapy
Comparison of the scores according to the EORTC Scoring Manual.
次要结局
- Acute hypersensitivity reactions assessed by the NCI CTCAE version 4.03(During the administration of paclitaxel (Day 1) of the second cycle of chemotherapy)
- Acute hypersensitivity reactions assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03(During the administration of paclitaxel (Day 1) of the first cycle of chemotherapy)
- Use of rescue medication(During the administration of paclitaxel (Day 1) of the second cycle of chemotherapy)
- Adverse effects self-assessed by a personal logbook(Assessed on a daily basis from Day 1 to Day 7 of the second cycle of chemotherapy)