A Phase 3 interventional study of Olanzapine and Metoclopramide in Nausea and Vomiting, sponsored by Affiliated Hospital of Qinghai University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Affiliated Hospital of Qinghai University · Phase 3, Interventional, and Prevention
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.
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.
644 studies on the registry are indexed under Nausea; 85 are open to participants now.
This study's planned enrollment of 222 is above the median of 96 across 544 interventional studies indexed under Nausea.
Browse Nausea studies →Affiliated Hospital of Qinghai University is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The group did not receive conventional additional preventive treatment.
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.
Drug: Olanzapine · Drug: Metoclopramide
Oral olanzapine (2.5mg per night, oral, 30 minutes before taking opioids on the first day of treatment), for 7 consecutive days.
Metoclopramide (10mg/ time, orally, 3 times a day) was taken orally for 7 days.
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.
During the 7-day study period after opioid treatment, the proportion of patients achieving CC was compared between the two groups.
Time frame: One week
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
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.
Time frame: One week
Proportion of patients adherent to strong opioid therapy during intervention period (Day 0-7) and extended follow-up (Day 8-14).
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.
Time frame: Two weeks
The proportion of patients without nausea in both groups during the study period (0-7 days after the start of opioid treatment);
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
Time frame: 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);
The proportion of patients without vomiting in the two groups during the study period (0-7 days after the start of opioid treatment);
Time frame: 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
The median time differences in the first occurrence of nausea and the first occurrence of vomiting between the two groups of patients
Time frame: 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;
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.
Time frame: 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)
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.
Time frame: 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.
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").
Time frame: 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).
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.
Time frame: 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.
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.
Time frame: One week
The difference in overall survival (OS) rates between the two groups.
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
Time frame: Half a year
Plan to share: Yes
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Studies of the drugs tested here: Olanzapine · Metoclopramide
Affiliated Hospital of Qinghai University