Clinical trial NCT05690802: The Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV
Official title: Palonosetron Hydrochloride Capsules (Ruoshan ®) Used to Prevent and Control Chemotherapy for Tumor Patients Real World Study on the Safety of Nausea and Vomiting Reduction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nausea and Vomiting
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 1060
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Palonosetron hydrochloride capsules
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Any adverse event after treatment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital, the Air Force Medical University
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Liu Hong, master
role: STUDY_CHAIR
References: