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

ConditionNausea and Vomiting

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorXijing Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Palonosetron hydrochloride capsules
Drug
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.

Treatment groups

1,060 Participants

are divided into 1 treatment group

Group A: Palonosetron hydrochloride capsulesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Any adverse event after treatment

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xijing Hospital

Lead sponsor

Source ClinicalTrials.gov

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