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Oral novel long-acting NK1 receptor antagonist + second-generation 5-HT3 receptor antagonist in the treatment of opioid-induced nausea and vomiting in patients with cancer pain clinical study protocol

Oral novel long-acting NK1 receptor antagonist + second-generation 5-HT3 receptor antagonist in the treatment of opioid-induced nausea and vomiting in patients with cancer pain clinical study protocol

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092551
Enrollment
Unknown
Registered
2024-11-19
Start date
2024-11-22
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Tumor

Interventions

experimental group:A novel long-acting NK1 receptor antagonist combined with a second-generation 5-HT3 receptor antagonist (Netopitant 300mg+ Palonosetron 0.5mg capsule)

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients with malignant tumors clearly diagnosed by pathology or histology. (2) More than moderate cancer pain, NRS score =4 points; (3) Age =18 years old; (4) Receiving oxycodone sustained release tablets/morphine hydrochloride sustained release tablets/morphine sulfate sustained release tablets for pain relief for the first time; (5) No systemic chemotherapy and radiotherapy in the past 1 month, and no drugs that may cause nausea and vomiting; (6) No discomfort such as nausea and vomiting at the time of selection; (7) Have normal understanding and communication skills.

Exclusion criteria

Exclusion criteria: (1) Patients diagnosed with breast cancer; (2) Accompanied by brain metastasis, pyloric obstruction, intestinal obstruction and other organic lesions that may cause nausea and vomiting; (3) long-term recipients of corticosteroids; (4) There has been nausea and vomiting within three days, regardless of the reason; (5) History of active gastrointestinal ulcer and gastrointestinal bleeding within one year; (6) Patients who cannot read or understand or complete the questionnaire independently; (7) Patients with poor compliance who are not expected to complete the study as planned; (8) Current participation in any other clinical trials or observational studies.

Design outcomes

Primary

MeasureTime frame
Complete response rate (CR) of OINV (Opioid-induced nausea and vomiting);

Secondary

MeasureTime frame
The analgesic effect after taking the medicine;The occurrence of other side reactions;Quality of life score;

Countries

China

Contacts

Public ContactZhu Jiang

West China Hospital, Sichuan University

zhujiang@wchscu.cn+86 189 8060 2256

Outcome results

None listed

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