Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting

NCT ID: NCT07208305

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-12-30

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.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

No intervention group

The group did not receive conventional additional preventive treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Olanzapine

Intervention Type: DRUG

Oral olanzapine (2.5mg per night, oral, 30 minutes before taking opioids on the first day of treatment), for 7 consecutive days.

Metoclopramide

Intervention Type: DRUG

Metoclopramide (10mg/ time, orally, 3 times a day) was taken orally for 7 days.

Interventions

Olanzapine

Oral olanzapine (2.5mg per night, oral, 30 minutes before taking opioids on the first day of treatment), for 7 consecutive days.

Intervention Type: DRUG

Metoclopramide

Metoclopramide (10mg/ time, orally, 3 times a day) was taken orally for 7 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with malignant tumors diagnosed by pathology or histology;

2. Patients diagnosed with locally advanced or advanced stages by imaging;

3. Age: 18 to 80 years old;

4. The eastern cooperative oncology group (ECOG) performance status of 0-3;

5. The expected survival period shall be no less than 4 weeks;

6. Moderate or severe cancer pain with a Numerical Rating Scale (NRS) score of ≥ 4 points;

7. Be able to take oral medication;

8. Initial treatment with potent opioid painkillers (such as morphine, oxycodone, fentanyl, etc.);

9. No systemic chemotherapy or radiotherapy was received within one month prior to selection, and no drugs that may induce nausea and vomiting were used.

10. There were no gastrointestinal discomforts such as nausea or vomiting at the time of selection, and no intestinal obstruction.

11. Possess normal comprehension and communication skills, be capable of completing research evaluations and following research procedures.

Exclusion Criteria

1. Diabetic patients with a clear diagnosis and poorly controlled blood sugar levels;

2. There are symptoms of nausea or vomiting;

3. Symptomatic intracranial diseases, such as brain metastases or leptomeningeal metastasis;

4. Received chemotherapy drug treatment within one week before the trial medication or during the trial period;

5. Receive radiotherapy for the head, abdomen or pelvic cavity within one week before the trial or during the trial;

6. New drugs with emetic or antiemetic effects have been used within 48 hours before the start of the trial;

7. Patients with severe electrolyte imbalance, abnormal kidney or liver function;

8. Patients with gastrointestinal bleeding;

9. Pregnant or lactating women;

10. Patients diagnosed with breast cancer;

11. Those whose electrocardiogram examination indicates heart disease or prolonged QTc interval;

12. There is a history of allergy or contraindications to olanzapine or metoclopramide.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Qinghai University

OTHER

Sponsor Role: lead

Responsible Party

Jiuda Zhao

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiuda Zhao, Doctor

Role: CONTACT

jiudazhao@126.com

09716230893

Facility Contacts

Jiuda Zhao, Doctor

Role: primary

jiudazhao@126.com

13327661976

Other Identifiers

AHQU-2025003

Identifier Type: -

Identifier Source: org_study_id