Actively Recruiting
Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting in Adults with Advanced Cancer
Led by Affiliated Hospital of Qinghai University · Updated on 2026-04-27
222
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial studies adult patients with advanced cancer who are starting strong opioid therapy. It evaluates whether combined treatment with olanzapine and metoclopramide can prevent nausea and vomiting caused by opioids. The study also monitors adverse events to understand the safety of this combination compared to no preventive treatment. Participants are randomly assigned to either receive olanzapine (2.5 mg once nightly) plus metoclopramide (10 mg three times daily) for seven days or no preventive treatment. Both groups may receive other treatments if nausea or vomiting occur. The trial lasts one week with a group receiving medication and a control group without preventive drugs. During the study, researchers track nausea, vomiting, time to first symptoms, duration of symptoms, opioid use, adverse events, pain levels using the Numeric Rating Scale, and quality of life with the EQ-5D-5L questionnaire. The main outcome is the percentage of patients with complete control of nausea and vomiting over seven days. Safety and survival rates are also followed up to half a year.
CONDITIONS
Brief Title
Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with malignant tumors confirmed by pathology or histology
- Diagnosed with locally advanced or advanced cancer stages by imaging
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- Expected to survive at least 4 weeks
- Moderate or severe cancer pain with a Numeric Rating Scale (NRS) score of 4 or higher
- Able to take oral medication
- Starting treatment with strong opioid painkillers such as morphine, oxycodone, or fentanyl
- No chemotherapy or radiotherapy within one month prior to enrollment
- No nausea, vomiting, or intestinal obstruction at the time of enrollment
- Capable of understanding and completing research evaluations and procedures
You will not qualify if you...
- Poorly controlled diabetes with clear diagnosis
- Currently experiencing nausea or vomiting symptoms
- Symptomatic brain diseases such as brain metastases or leptomeningeal metastasis
- Chemotherapy within one week before or during the trial
- Radiotherapy to head, abdomen, or pelvis within one week before or during the trial
- Use of drugs with emetic or antiemetic effects within 48 hours before trial start
- Severe electrolyte imbalance or abnormal kidney or liver function
- Gastrointestinal bleeding
- Pregnant or breastfeeding women
- Diagnosed with breast cancer
- Heart disease or prolonged QTc interval on electrocardiogram
- Known allergy or contraindication to olanzapine or metoclopramide
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive oral olanzapine once daily at night plus oral metoclopramide three times daily for 7 consecutive days to prevent opioid-induced nausea and vomiting. Participants in the control group do not receive preventive treatment.
Daily oral medication for 7 days
Duration - 7 days
Participants are monitored for adherence to opioid therapy and assessed for symptoms and side effects for an additional week after treatment ends.
Follow-up assessments during days 8 to 14
Trial Site Locations
Total: 1 location
1
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810000
Actively Recruiting
Research Team
J
Jiuda Zhao, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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