RecruitingNot ApplicableNCT05690802

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

Palonosetron Hydrochloride Capsules (Ruoshan ®) Used to Prevent and Control Chemotherapy for Tumor Patients Real World Study on the Safety of Nausea and Vomiting Reduction

Sponsor

Xijing Hospital

Enrollment

1,060 participants

Start Date

May 16, 2022

Study Type

INTERVENTIONAL

Conditions

Nausea and Vomiting

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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);
-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 Criteria3

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.

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Interventions

DRUGPalonosetron hydrochloride capsules

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.