Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- The proportion of patients with complete control (CC) in both groups during the study period (0-7 days after the initiation of opioid treatment); CC is defined as: no vomiting attack, no rescue medications are used, and no nausea.
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of olanzapine plus metoclopramide in preventing opioid-induced nausea and vomiting (OINV) in adult patients with advanced cancer who are initiating strong opioid therapy. The main questions it aims to answer are: (1) Does the combination of olanzapine and metoclopramide reduce the incidence of OINV? (2)What adverse events do participants experience when taking the combination of olanzapine and metoclopramide? Researchers will compare the olanzapine-metoclopramide combination to a no prophylactic treatment control group to determine whether the combination is effective in preventing OINV.
Participants will: Take olanzapine (2.5 mg/day ) and metoclopramide (10 mg three times daily) or receive no prophylaxis for 7 days; Through follow-up, nausea, vomiting, the time of the first attack of nausea and vomiting, the duration of nausea and vomiting, the use of strong opioids and adverse events were evaluated and recorded, as well as the pain score (using NRS) and quality of life (EQ-5D-5L) of the patients were evaluated at baseline and on day 7.
详细描述
Patients were randomly assigned in a 1:1 ratio to: The study group received olanzapine 2.5mg qn+ metoclopramide 10mg tid po for a total of 7 days for preventive treatment; The control group did not receive preventive treatment. Both groups could receive other treatments recommended by doctors after the appearance of OINV.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malignant tumors diagnosed by pathology or histology;
- •Patients diagnosed with locally advanced or advanced stages by imaging;
- •Age ≥ 18 years old;
- •The eastern cooperative oncology group (ECOG) performance status of 0-3;
- •The expected survival period shall be no less than 4 weeks;
- •Moderate or severe cancer pain with a Numerical Rating Scale (NRS) score of ≥ 4 points;
- •Be able to take oral medication;
- •Initial treatment with potent opioid painkillers (such as morphine, oxycodone, fentanyl, etc.);
- •No systemic chemotherapy or radiotherapy was received within one month prior to selection, and no drugs that may induce nausea and vomiting were used.
- •There were no gastrointestinal discomforts such as nausea or vomiting at the time of selection, and no intestinal obstruction.
- •Possess normal comprehension and communication skills, be capable of completing research evaluations and following research procedures.
排除标准
- •Diabetic patients with a clear diagnosis and poorly controlled blood sugar levels;
- •There are symptoms of nausea or vomiting;
- •Symptomatic intracranial diseases, such as brain metastases or leptomeningeal metastasis;
- •Received chemotherapy drug treatment within one week before the trial medication or during the trial period;
- •Receive radiotherapy for the head, abdomen or pelvic cavity within one week before the trial or during the trial;
- •New drugs with emetic or antiemetic effects have been used within 48 hours before the start of the trial;
- •Patients with severe electrolyte imbalance, abnormal kidney or liver function;
- •Patients with gastrointestinal bleeding;
- •Pregnant or lactating women;
- •Patients diagnosed with breast cancer;
- •Those whose electrocardiogram examination indicates heart disease or prolonged QTc interval;
- •There is a history of allergy or contraindications to olanzapine or metoclopramide.
研究组 & 干预措施
Olanzapine plus metoclopramide group
The experimental group received olanzapine (2.5mg/ night, oral, taken 30 minutes before opioid drugs on the first day of treatment) plus metoclopramide (10mg/ time, oral, 3 times a day) for 7 days.
干预措施: Olanzapine (Drug)
Olanzapine plus metoclopramide group
The experimental group received olanzapine (2.5mg/ night, oral, taken 30 minutes before opioid drugs on the first day of treatment) plus metoclopramide (10mg/ time, oral, 3 times a day) for 7 days.
干预措施: Metoclopramide (Drug)
No intervention group
The group did not receive conventional additional preventive treatment.
结局指标
主要结局
The proportion of patients with complete control (CC) in both groups during the study period (0-7 days after the initiation of opioid treatment); CC is defined as: no vomiting attack, no rescue medications are used, and no nausea.
时间窗: One week
During the 7-day study period after opioid treatment, the proportion of patients achieving CC was compared between the two groups.
次要结局
- The proportion of patients in the two groups who achieved complete response (CR) during the study period (0-7 days after the initiation of opioid treatment); CR is defined as patients who have no vomiting/retching or rescue medications(One week)
- Proportion of patients adherent to strong opioid therapy during intervention period (Day 0-7) and extended follow-up (Day 8-14).(Two weeks)
- The proportion of patients without nausea in both groups during the study period (0-7 days after the start of opioid treatment);(One week)
- The proportion of patients without vomiting in the two groups during the study period (0-7 days after the start of opioid treatment);(One week)
- During the study period(0-7 days after the initiation of opioid treatment), the median time differences in the first occurrence of nausea and the first occurrence of vomiting between the two groups of patients(One week)
- During the study period (0-7 days after the start of opioid treatment), the difference in the cumulative duration of nausea and vomiting attacks between the two groups of patients;(One week)
- The differences in the proportion of patients who did not use rescue antiemetics and the cumulative use of rescue antiemetics between the two groups during the study period (0-7 days after the initiation of opioid therapy)(One week)
- The proportion of patients who achieved cancer pain relief (defined as an Numeric Rating Scale (NRS) score ≤ 3 points) from baseline to the end of the 7-day intervention.(One week)
- The difference in the change of quality of life between the two groups from baseline to the end of the 7-day intervention, as assessed by the European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L).(One week)
- Incidence of treatment-emergent adverse events related to olanzapine or metoclopramide during the 7-day study period, graded by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.(One week)
- The difference in overall survival (OS) rates between the two groups.(Half a year)
研究者
Jiuda Zhao
Doctor
Affiliated Hospital of Qinghai University