Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patients - A Confirmatory Phase III MNCCTN Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Change in nausea score
研究概览
简要总结
This phase III trial compares olanzapine to placebo in decreasing nausea and vomiting in patients with cancer that has spread to other places in the body (advanced). Patients with advanced cancer may experience nausea and/or vomiting that is unrelated to chemotherapy or radiation. Giving olanzapine may help reduce nausea and increase appetite in patients who have advanced cancer.
详细描述
PRIMARY OBJECTIVE:
I. To conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated nausea/vomiting.
SECONDARY OBJECTIVES:
I. To evaluate toxicity associated with olanzapine in patients with advanced-cancer associated nausea/vomiting.
II. To evaluate the effect of olanzapine on appetite, vomiting, sedation, sleep, the use of other antiemetic agents, fatigue, and well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Age >= 18 years
- •Histologically or cytologically-confirmed cancer in an advanced incurable stage
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- •Chronic nausea that has been present for at least one week (daily score > 5, on a 0-10 visual analogue scale)
- •Serum creatinine < 2.0 mg/dl =< 120 days prior to registration
- •Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) values < 3 times upper limits of normal =< 120 days prior to registration
- •Negative pregnancy test done =< 14 days prior to registration, for persons of childbearing potential only
- •Able to provide written informed consent
- •Able to complete questionnaire(s) by themselves or with assistance
排除标准
- •Any of the following because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects:
- •Pregnant persons
- •Nursing persons
- •Received chemotherapy or radiation within the prior 14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible)
- •Receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for =< 30 days prior to registration or planned during protocol therapy (patients may have received prochlorperazine and other phenothiazines as prior anti-emetic therapy)
- •Those with concurrent use of ethyol; severe cognitive compromise; concurrent use of amifostine; concurrent use of quinolone antibiotic therapy; known hypersensitivity to olanzapine; or have planned chemotherapy or radiation during the 7 days following study initiation
- •Uncontrolled intercurrent illness including, but not limited to:
- •Ongoing or active infection (including human immunodeficiency virus [HIV])
- •Cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Inability to swallow oral formulations of the agent(s)
- •Tube feeding or nasogastric tube
研究组 & 干预措施
Arm I (olanzapine)
Patients receive olanzapine PO every night on days 1-28.
干预措施: Olanzapine (Drug)
Arm I (olanzapine)
Patients receive olanzapine PO every night on days 1-28.
干预措施: Questionnaire Administration (Other)
Arm II (placebo, olanzapine)
Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.
干预措施: Olanzapine (Drug)
Arm II (placebo, olanzapine)
Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.
干预措施: Placebo Administration (Drug)
Arm II (placebo, olanzapine)
Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in nausea score
时间窗: Baseline to 24 hours of treatment
Evaluated using Visual Analogue Scale. Nausea scores at baseline and after the first two days and the change scores, for the first 2 days, will be summarized using mean (standard deviation) and median (range). The change scores from baseline to the end of the first 2 days will be compared between arms using a two-sample t-test or a Wilcoxon rank sum test as appropriate. The difference in nausea change scores from baseline to 2 days post treatment initiation between the two arms will be estimated along with a 95% confidence interval.
次要结局
- Daily nausea and vomiting scores(Up to 28 days)
- Daily episodes of vomiting/retching (number and time)(Up to 28 days)
- Incidence of adverse events with olanzapine(Up to 28 days)
- Utilization of rescue therapy(Up to 28 days)