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A randomized, controlled, open label study on the prevention of nausea and vomiting induced by opioid drugs in patients with lung cancer pain using netupitan palonosetron capsules

A randomized, controlled, open label study on the prevention of nausea and vomiting induced by opioid drugs in patients with lung cancer pain using netupitan palonosetron capsules

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108969
Enrollment
Unknown
Registered
2025-09-09
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer pain receiving opioid therapy

Interventions

Control group:Ondansetron capsules (8mg/capsule) should be taken preventively seven days before the opioid treatment regimen and half an hour before receiving opioi
Experimental group:3 hours before opioid treatment, take one tablet of Natupine Tampa Loxosetron orally

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Lung cancer patients diagnosed by pathology or histology; 2. Moderate and severe cancer pain patients, NRS score >= 4 points; 3. Individuals at high risk of vomiting after opioid therapy, such as those without a history of alcohol consumption or those with a history of nausea and vomiting; 4. Patients who plan to receive analgesic treatment with sustained-release morphine hydrochloride tablets for the first time; 5. Age >= 18 years old, expected survival>12 weeks; 6. Not receiving systemic chemotherapy or radiotherapy in the past two weeks, and not taking any other medication that may cause nausea and vomiting; 7. There were no adverse reactions such as nausea and vomiting during the selection process; 8. Sign an informed consent form before screening, fully understand the trial content, process, and possible adverse reactions, and be able to complete the study according to the requirements of the trial protocol.

Exclusion criteria

Exclusion criteria: 1. People with organic lesions such as brain metastasis, pyloric obstruction, and intestinal obstruction that may cause nausea and vomiting; 2. Patients with motion sickness, Meniere syndrome, pregnant or lactating women, and those with fertility who are unwilling or unable to take effective contraceptive measures; 3. Have experienced nausea or vomiting for any reason within the two weeks prior to screening; 4. People with swallowing difficulties; 5. Patients who cannot read, understand, or independently complete the questionnaire survey; 6. Patients with poor compliance who are expected to be unable to complete the study as planned; 7. Currently participating in any other clinical trials or observational studies; 8.Researchers believe that individuals who are not suitable to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
Incidence of nausea and vomiting (OINV) during opioid therapy;

Secondary

MeasureTime frame
The Nausea and Vomiting Questionnaire (FLIE) evaluates the impact of medication on patients' daily activities of life;The non significant nausea (No nausea, no vomiting)rate of nausea and vomiting after treatment;Record and evaluate all adverse events, including serious adverse events;Laboratory evaluation (hematology, blood biochemistry, and urine analysis);Non emergency medication rate of patients after treatment;Vital signs and physical examination;Successful rescue rate of breakthrough vomiting;

Countries

China

Contacts

Public ContactAimin Zhang

Sichuan Cancer Hospital

zhangaimin@scszlyy.org.cn+86 13558115400

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026