NauseaPhase 3NCT07208305
Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting
A Phase 3 study testing Olanzapine and Metoclopramide in people with Nausea and Vomiting, run by Affiliated Hospital of Qinghai University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Olanzapine and Metoclopramide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2026to 30 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
Jiuda Zhao, Doctor, 13327661976, jiudazhao@126.com
About this study
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.
Read the 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.
- Being tested
- Olanzapine, Metoclopramide
- Keywords
- Olanzapine, Metoclopramide, Opioid, Nausea, Vomiting
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Oral olanzapine (2.5mg per night, oral, 30 minutes before taking opioids on the first day of treatment), for 7 consecutive days.
MetoclopramideDrug
Metoclopramide (10mg/ time, orally, 3 times a day) was taken orally for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| No intervention group | No intervention | The group did not receive conventional additional preventive treatment. |
| Olanzapine plus metoclopramide group | Active comparator | 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. Receives: Drug: Olanzapine; Drug: Metoclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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
Measured: 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);
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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
Measured: Half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start3 Feb 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Qinghai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208305
- Sponsor's protocol ID
- AHQU-2025003
- Status last verified
- Apr 2026
- First submitted
- 21 Sep 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT07208305
- Acronym / sponsor ID
- AHQU-2025003
- Keywords
- Olanzapine, Metoclopramide, Opioid, Nausea, Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Qinghai UniversityUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention group | No intervention | –The group did not receive conventional additional preventive treatment. |
| Olanzapine plus metoclopramide group | Active comparator | Drug: Olanzapine, Drug: MetoclopramideThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlanzapineOral olanzapine (2.5mg per night, oral, 30 minutes before taking opioids on the first day of treatment), for 7 consecutive days. | Drug | Olanzapine plus metoclopramide group |
| MetoclopramideMetoclopramide (10mg/ time, orally, 3 times a day) was taken orally for 7 days. | Drug | Olanzapine plus metoclopramide group |
Primary outcome
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.
Time frame: One week
During the 7-day study period after opioid treatment, the proportion of patients achieving CC was compared between the two groups.
11 secondary outcomes
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
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).
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);
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);
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
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;
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)
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.
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).
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.
Time frame: One week
The difference in overall survival (OS) rates between the two groups.
Time frame: Half a year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine and Metoclopramide in people with Nausea and Vomiting, run by Affiliated Hospital of Qinghai University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiuda Zhao, Doctor (09716230893, jiudazhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.