FORESIGHT: Feasibility of Olanzapine at REduced doSe in hIGHly Emetogenic chemoTherapy: a Randomised Controlled Trial Against Aprepitant in Triple Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of patients recruited
研究概览
简要总结
Olanzapine is frequently used off-label as an adjunct antiemetic in clinical oncology settings. North American oncology guidelines recommend it as salvage therapy and as add-on to the standard triple regimen; some suggest it may also be effective as an initial triple therapy (olanzapine replacing the NK-1 antagonist) based on phase II and III trials.
This prospective, multi-center, open-label study aims to evaluate the feasibility of a large scale randomised controlled trial to compare the effectiveness and tolerability of 5mg orally once daily olanzapine in triple antiemetic therapy versus the standard treatment of aprepitant + ondansetron + dexamethasone in treatment-naive patients receiving the first cycle of a highly emetogenic chemotherapy. Secondary outcomes include effectiveness, tolerability and quality of life assessments. Effectiveness will be measured with complete response and complete remission rates in each treatment arms. Tolerability and patient quality of life will be evaluated with a standardised side effect form and validated questionnaires; ESAS-R and FLIE.
The role of olanzapine-based triple therapy in prevention of chemotherapy-induced nausea and vomiting remains founded on low-quality evidence. To the investigator's knowledge, this study will be the first large scale direct comparison of 5mg olanzapine versus aprepitant in triple therapy.
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
- None
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
- •Patients receiving a first cycle of highly emetogenic chemotherapy (or having received one more than 2 years prior to randomisation) at the oncology outpatient clinic at Charles LeMoyne or Haut-Richelieu hospital between April 29th and September 20th
- •18 years old and over
- •Patient receiving highly emetogenic chemotherapy
- •ECOG from 0 to 2 inclusively
- •Creatinine clearance ≥ 30ml/min; total bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 3.0 x ULN
- •Patient without electrolytic imbalance or corrected imbalance
- •Signed written and informed consent
排除标准
- •Patient doesn't speak french or english
- •Patient to receive treatment whose protocol includes a second dose of highly emetogenic chemotherapy before day 6 of the cycle
- •Patient to receive chemotherapy treatment that already contains corticosteroids (dexamethasone or prednisone) given as antineoplastic
- •Nausea or vomiting present ≤ 24h before randomisation
- •Untreated brain metastases
- •Severe cognitive disorder or dementia or inability to properly understand or document the presence of nausea or vomiting or the use of salvage therapy
- •History of uncontrolled cardiac arrhythmia, unstable angina or known QT prolongation (> 500ms)
- •Uncontrolled diabetes
- •Patient to receive abdominal radiotherapy during the first cycle of chemotherapy
- •Bowel obstruction, intestinal ileus or ascites present at cycle 1
- •Chronic alcoholism
- •Severe uncontrolled psychologic disorder
- •Patient taking antipsychotic treatment on a regular basis
- •Patient taking drugs with a contraindication when administered concurrently with one of the protocol drugs
- •Dysphagia (incapacity to swallow the pills included in the study)
- •Hypersensitivity, severe reaction or allergy to one of the study treatments
- •Participation in another research protocol
- •Pregnancy or breastfeeding
- •Subject that does not have a valid phone ou email address
研究组 & 干预措施
Study treatment group
Olanzapine in combination with ondansetron and dexamethasone
干预措施: Zyprexa® (OLANZapine 5MG) (Drug)
Standard treatment group
Aprepitant in combination with ondansetron and dexamethasone
干预措施: Emend® (Aprepitant) (Drug)
结局指标
主要结局
Number of patients recruited
时间窗: 5 months
At least 60 patients over 5 months meet the eligibility criteria and agree to participate.
Eligible patients' interest to participate
时间窗: 5 months
At least 35% of all eligible patients agree to participate
Completion of the diary
时间窗: 5 months
At least 75% of recruited patients complete 100% of their patient diary.
Cost
时间窗: 5 months
The total cost of the study does not exceed 10,000$
Number of centres
时间窗: 5 months
The study can be done at two sites.
次要结局
- Compare effectiveness of olanzapine 5mg versus standard aprepitant in a triple antiemetic therapy in patients receiving a first cycle of highly emetogenic chemotherapy in regard of proportion of participant with complete response in the overall phase.(0 to 120 hours)
- Compare effectiveness of olanzapine 5mg versus standard aprepitant in a triple antiemetic therapy in patients receiving a first cycle of highly emetogenic chemotherapy in regard of proportion of participant with complete remission in the overall phase.(0 to 120 hours)
- Compare tolerability of olanzapine 5mg versus standard aprepitant in a triple antiemetic therapy in patients receiving a first cycle of highly emetogenic chemotherapy in regard of prevalence of adverse events due to the antiemetic therapy in each arm.(During the complete duration of the first cycle of chemotherapy (1 cycle is 14 to 28 days))
- Compare patient's assessment of quality of life between those receiving olanzapine 5mg and those receiving standard aprepitant in a triple antiemetic therapy in patients receiving a first cycle of highly emetogenic chemotherapy.(0 to 120 hours)