The Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV
- Conditions
- Nausea and Vomiting
- Interventions
- Registration Number
- NCT05690802
- Lead Sponsor
- Xijing Hospital
- Brief Summary
To observe and evaluate the safety and effectiveness of Palonosetron hydrochloride capsule in preventing acute nausea and vomiting caused by moderate emetic chemotherapy; The characteristics of the applicable population, clinical medication and clinical benefits of Palonosetron Hydrochloride Capsules were analyzed.
- Detailed Description
At present, as the mainstream antiemetics of CINV, oral administration is the most commonly used method of drug therapy. Clinical studies showed that there was no difference in the efficacy of 5-HT3 receptor antagonist between different administration routes (oral and intravenous). At the same time, because the oral route is the most convenient, oral preparations provide more and more convenient choices for clinicians and patients. To observe and evaluate the safety and effectiveness of Palonosetron hydrochloride capsule in preventing acute nausea and vomiting caused by moderate emetic chemotherapy; The characteristics of the applicable population, clinical medication and clinical benefits of Palonosetron Hydrochloride Capsules were analyzed.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1060
- For patients with malignant tumors who can accept chemotherapy, the disease type is not limited. The specific chemotherapy scheme is the chemotherapy scheme with moderate risk of vomiting (for the risk level of vomiting, refer to the 2019 CSCO anti-tumor treatment related nausea and vomiting prevention and treatment guidelines);
- 18-75 years old, KPS score ≥ 70, and the expected survival time is more than 3 months;
- Before treatment, ECG, blood routine test, liver and kidney functions and electrolytes were basically normal;
- All patients signed the informed consent form
- Patients with chemotherapy contraindications, patients allergic to 5-HT3RA, pregnant women and lactating women;
- People with digestive tract obstruction; Patients with serious heart disease, liver and kidney disease and metabolic disorder; Patients suffering from epilepsy or using psychotropic and sedative drugs;
- Used antiemetic drugs or chemicals within 24 hours.Those who have vomited before treatment may have brain metastasis, intracranial hypertension, gastrointestinal obstruction, psychological abnormalities, etc.Patients with factors causing nausea and vomiting.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Palonosetron hydrochloride capsules Palonosetron hydrochloride capsules The recommended dose for adults is 0.5mg (1 capsule) for a single oral dose about 1 hour before chemotherapy.
- Primary Outcome Measures
Name Time Method Any adverse event after treatment 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Affiliated Hospital, the Air Force Medical University
🇨🇳Xi'an, Shaanxi, China