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A randomized, double-blind, controlled, multicenter prospective clinical trial of Huoxiang Zhengqi Oral Liquid to prevent chemotherapy-induced nausea and vomiting following platinum-containing multi-day chemotherapy

A randomized, double-blind, controlled, multicenter prospective clinical trial of Huoxiang Zhengqi Oral Liquid to prevent chemotherapy-induced nausea and vomiting following platinum-containing multi-day chemotherapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000004069
Enrollment
Unknown
Registered
2020-11-21
Start date
2020-12-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

tumor

Interventions

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of cancer; 2. Aged 18 to 70 years; 3. Accept chemotherapy for the first time and about to receive cisplatin (multi-day) highly emetogenic combination regimen or monotherapy regimen; 4. No history of chronic gastrointestinal diseases (such as chronic gastroenteritis, etc.), and no history of chronic nausea and vomiting (such as vertigo, Meniere disease, etc.); 5. Hematology, liver, kidney function, heart function and other important organ functions meet the requirements of chemotherapy.

Exclusion criteria

Exclusion criteria: 1. Have not yet controlled cancer pain, and need to titrate cancer pain or adjust the dose of opioid painkillers, or the digestive tract reaction of opioids has not been completely controlled; 2. Chronic receives corticosteroids; 3. Nausea and vomiting are caused for whatever reason in three days; 4. History of active gastrointestinal ulcer and gastrointestinal hemorrhage within one year; 5. Unable to read or understand the questionnaire or cannot complete the questionnaire independently; 6. Poor compliance and unable to complete the study as planned; 7. Cannot tolerate the smell of Huoxiang Zhengqi oral liquid or allergic to Huoxiang Zhengqi oral liquid; 8. Currently involved in any other clinical trial or observational study.

Design outcomes

Primary

MeasureTime frame
Outside risk phase CINV complete response rate;Risk phase CINV complete response rate;

Countries

China

Contacts

Public ContactJiang Zhu

West China Hospital, Sichuan University

zhujiang@wchscu.cn+86 18980602256

Outcome results

None listed

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