The Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV (TSEPHCC)

Air Force Military Medical University of People's Liberation Army

Status

Enrolling

Conditions

Nausea and Vomiting

Treatments

Drug: Palonosetron hydrochloride capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT05690802

TQXB-R-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,060 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.