About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Olanzapine
DrugOral olanzapine (2.5mg per night, oral, 30 minutes before taking opioids on the first day of treatment), for 7 consecutive days.
Metoclopramide
DrugMetoclopramide (10mg/ time, orally, 3 times a day) was taken orally for 7 days.
Treatment groups
Trial outcomes
Primary outcomes
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.
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
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).
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);
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);
The proportion of patients without vomiting in the two groups during the study period (0-7 days after the start of opioid treatment);
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