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

NCT ID: NCT05690802

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1060 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2029-05-30

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.

Conditions

Nausea and Vomiting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Palonosetron hydrochloride capsules

The recommended dose for adults is 0.5mg (1 capsule) for a single oral dose about 1 hour before chemotherapy.

Group Type: EXPERIMENTAL

Palonosetron hydrochloride capsules

Intervention Type: 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.

Interventions

Palonosetron 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.

Intervention Type: DRUG

Other Intervention Names

Ruoshan ®

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liu Hong, master

Role: STUDY_CHAIR

Air Force Military Medical University, China

Locations

The First Affiliated Hospital, the Air Force Medical University

Xi'an, Shaan'xi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liu Hong, master

Role: CONTACT

hongliu1@fmmu.edu.cn

13709284513

Wei Zhou, master

Role: CONTACT

252376698@qq.com

13720542643

Facility Contacts

Liu Hong, master

Role: primary

hongliu1@fmmu.edu.cn

13709284513

Other Identifiers

TQXB-R-001

Identifier Type: -

Identifier Source: org_study_id