Nausea and Vomiting
Conditions
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.
Interventions
This protocol only stipulates Palonosetron capsule containing hydrochloric acid protocol, and does not make uniform provisions on the treatment course, and does not interfere with the actual clinical usage and dosage.
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Palonosetron hydrochloride capsules
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any adverse event after treatment | 1 year |
Countries
China
Contacts
Primary ContactLiu Hong, master
Backup ContactWei Zhou, master
Outcome results
None listed