Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting
- Registration Number
- NCT07208305
- Lead Sponsor
- Affiliated Hospital of Qinghai University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 222
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olanzapine plus metoclopramide group Olanzapine 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. Olanzapine plus metoclopramide group Metoclopramide 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.
- Primary Outcome Measures
Name Time Method 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. One week During the 7-day study period after opioid treatment, the proportion of patients achieving CC was compared between the two groups.
- Secondary Outcome Measures
Name Time Method 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 The proportion of patients achieving overall stage complete response is defined aspatients who have no vomiting/retching or rescue medications during 0 to 7 days after the initiation of opioid treatment.
Proportion of patients adherent to strong opioid therapy during intervention period (Day 0-7) and extended follow-up (Day 8-14). Two weeks Adherence will be assessed based on both daily opioid use and prescribed dose compliance. The results will be summarized as the percentage of adherent patients in each study group for Day 0-7 and Day 8-14.
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 nausea in both groups during the study period (0-7 days after the start of opioid treatment); The definition of no nausea is: the visual analogue scale score = 0
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 The proportion of patients without vomiting in the two groups during the study period (0-7 days after the start of opioid treatment);
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 The median time differences in the first occurrence of nausea and the first occurrence of vomiting between the two groups of patients
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 difference in the total duration of nausea and vomiting episodes between the two treatment groups was assessed over the 7-day study period following opioid initiation. For each patient who experienced symptoms, the cumulative duration (in days) of all nausea and vomiting events was calculated based on daily diary entries and follow-up records. The mean or median of these cumulative durations was then compared between the intervention and control groups.
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 need for rescue antiemetics was assessed by comparing both the proportion of patients who remained rescue-free and the mean number of rescue medication administrations per patient between the two groups during the 7-day intervention period.
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 NRS is a validated, 11-point scale widely used for self-reporting cancer pain intensity. Patients are asked to rate their pain from 0 (representing "no pain") to 10 (representing "the worst pain imaginable").
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 The quality of life will be evaluated using the EQ-5D-5L questionnaire, which is a standardized tool consisting of five dimensions (activity ability, self-care, daily activities, pain/discomfort, anxiety/depression), with each dimension having five levels. The score will be converted into a single indicator value, ranging from -0.594 to 1.000 (where 1.000 represents the full life value and a lower score indicates a poorer health status). The higher the score, the better the health condition. The main analysis will compare the average change of the EQ-5D-5L index score from baseline to day 7 between the intervention group and the control group.
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 safety profile of the prophylactic regimen will be assessed by comparing the proportion of patients in each group who experience at least one adverse event related to olanzapine or metoclopramide during the 7-day study period. All adverse events will be graded for severity according to the NCI CTCAE v5.0.
The difference in overall survival (OS) rates between the two groups. Half a year After the study began, survival follow-up was conducted on the patients, recording the time from the start of the study to the occurrence of the event or the follow-up, as well as the survival status of the patients
Trial Locations
- Locations (1)
Qinghai University Affiliated Hospital
🇨🇳Xining, Qinghai, China
Qinghai University Affiliated Hospital🇨🇳Xining, Qinghai, ChinaJiuda Zhao, DoctorContact13327661976jiudazhao@126.com