Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patient - A Pilot, Dose-Finding Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Mean Nausea Scores
研究概览
简要总结
The purpose of this study is to evaluate the use of olanzapine for the treatment of cancer patients with chronic nausea and/or vomiting unrelated to chemotherapy or radiation in a randomized placebo-controlled pilot trial.
详细描述
Patients with advanced cancer experience a variety of physical and psychosocial symptoms that significantly affect the patients' quality of life. Chronic nausea is a particularly distressing symptom present in >60% of patients with advanced cancer. A number of palliative care studies have evaluated treatments of nausea with limited success. Olanzapine with its unique formulation and decreased drug interactions compared to many other drugs appears to be a reasonable candidate for further evaluation. Olanzapine has significant potential for use in the prevention and treatment of nausea in a palliative care setting with a once-daily dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Patients will receive the study drug or placebo in a double-blind fashion.
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
- •Be at least 18 years of age
- •Have histologically or cytologically-confirmed malignant disease in an advanced incurable stage
- •Have not received chemotherapy or radiation for >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)
- •Have chronic nausea that has been present for at least one week (worst daily score >3, 0-10 visual analogue scale) or vomiting at least five times over past one week
- •Have serum creatinine < 2.0 mg/dl and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) < 3 times upper limits of normal ≤120 days prior to registration
- •Absolute neutrophil count (ANC) >1500 mm3 <120 days prior to registration
- •Women of childbearing potential must consent to use adequate contraception throughout protocol therapy; females of childbearing potential must have a negative urine pregnancy test <7 days prior to registration.
排除标准
- •Not be receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for less than or equal to 30 days prior to registration or planned during protocol therapy (patients may have received prochlorperazine and other phenothiazines as prior anti-emetic therapy)
- •Not have concurrent use of ethyol
- •Not have severe cognitive compromise
- •History of central nervous system (CNS) disease (e.g. brain metastases, seizure disorder)
- •Concurrent use of amifostine, concurrent abdominal radiotherapy; concurrent use of quinolone antibiotic therapy
- •Chronic alcoholism (as determined by the investigator)
- •Known hypersensitivity to olanzapine
- •Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months
- •History of uncontrolled diabetes mellitus (stable insulin dose and/or stable oral hypoglycemic agent permitted)
- •Planned chemotherapy or radiation during the 7 days following study initiation.
研究组 & 干预措施
Olanzapine
Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.
干预措施: Olanzapine (Drug)
Placebo
Patients will receive a placebo orally for 1 to 7 days daily.
干预措施: Placebo (Other)
结局指标
主要结局
Mean Nausea Scores
时间窗: Nausea score from the Visual Analogue Scale will be recorded each day daily for 7 days. An average value calculated will be reported for the 7 day period.
Daily nausea scores (the primary objective) on day 1 to 7 of treatment for each patient from the Olanzapine and Placebo group will be measured using the Visual Analogue Scale rankings from 0-10 where 0 is no nausea and 10 is the maximum nausea experienced by a patient. A Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that can't be directly measured. Patients will be asked to record the average nausea score for each day in a diary and a study nurse will call the patient at the same time each day to remind the patient to record the nausea score and to inquire about any toxicities. The difference in the nausea scores for the patients in each group (Olanzapine and Placebo) will be compared.
次要结局
- Number of Emetic Episodes(Number of emetic episodes for each patient on each day of the seven day treatment.)
- Number of Treatment-related Adverse Events as Assessed by CTCAE v4.0".(Daily assessment for 7 days for each patient in Olanzapine & Placebo Groups.)
研究者
Rudolph Navari
Professor
University of Alabama at Birmingham