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
- Conditions
- tumor
- Registration Number
- ITMCTR2000004069
- Lead Sponsor
- West China Hospital, Sichuan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outside risk phase CINV complete response rate;Risk phase CINV complete response rate;
- Secondary Outcome Measures
Name Time Method