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A randomized, double-blind, controlled, multicenter phase III clinical trial of Huoxiang Zhengqi Oral Liquid to prevent and control cisplatin-induced (multi-day) chemotherapy-induced nausea and vomiting (CINV)

A randomized, double-blind, controlled, multicenter phase III clinical trial of Huoxiang Zhengqi Oral Liquid to prevent and control cisplatin-induced (multi-day) chemotherapy-induced nausea and vomiting (CINV)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069212
Enrollment
Unknown
Registered
2023-03-09
Start date
2023-03-09
Completion date
Unknown
Last updated
2023-05-29

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:Huoxiang Zhengqi oral liquid+dexamethasone+5-HT3RA
Experimental group B:Dexamethasone+5-HT3RA

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with pathological diagnosis of malignant tumor; 2. Aged 18-70 years; 3. Receiving chemotherapy for the first time (those who had received adjuvant chemotherapy in the past could be enrolled, but more than 6 months had passed since the end of the last chemotherapy), and the chemotherapy regimen was highly emetic chemotherapy containing cisplatin (three days) in combination or single drug regimen (Cetuximab, trizumab, rituximab, bevacizumab, and ICIs immunotherapy drugs were allowed; The combination of TKIs targeted drugs is not allowed); 4. No history of chronic digestive tract diseases (such as chronic gastritis, chronic enteritis, etc.), no history of chronic nausea and vomiting (such as vertigo, Meniere syndrome, etc.); 5. Huoxiang Zhengqi oral liquid can be taken smoothly; 6. Hematology, liver and kidney function, heart function and important organ function indexes meet the requirements of chemotherapy; 7. NK1RAs cannot be used for preventive antiemesis for various reasons; 8. Informed and agreed to participate in the clinical trial, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have not yet controlled stable cancer pain, need to titrate or adjust the dose of opioid painkillers for cancer pain, or whose digestive reactions to opioids have not been completely controlled; 2. Patients receiving long-term corticosteroid therapy; 3. Any nausea or vomiting caused by any reason within three days; 4. Patients with brain metastases with intracranial hypertension; 5. The investigator judged that the patient could not complete the study as planned.

Design outcomes

Primary

MeasureTime frame
Average number of nausea and vomiting-free days (NCDs) throughout the entire cycle;Complete control rate of CINV outside of the risk phase;

Secondary

MeasureTime frame
Safety;Complete control rate of CINV during the risk phase;Incidence and severity of nausea outside of the risk phase;Quality of life score;

Countries

China

Contacts

Public ContactZhu Jiang

West China Hospital, Sichuan University

zhujiang@wchscu.cn+86 18980602256

Outcome results

None listed

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