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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nausea and Vomiting
• Intervention / Treatment: Drug: Palonosetron hydrochloride capsules

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1060
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liu Hong, master; Phone Number: 13709284513; Email: hongliu1@fmmu.edu.cn
• Study Contact Backup: Name: Wei Zhou, master; Phone Number: 13720542643; Email: 252376698@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • The First Affiliated Hospital, the Air Force Medical University
      • Contact: Liu Hong, master; Phone Number: 13709284513; Email: hongliu1@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Palonosetron hydrochloride capsules; The recommended dose for adults is 0.5mg (1 capsule) for a single oral dose about 1 hour before chemotherapy.	Drug: 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.; Other Names: Ruoshan ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Any adverse event after treatment	1 year

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Liu Hong, master, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Anticipated): May 30, 2027
• Study Completion (Anticipated): May 30, 2029

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Palonosetron
• Other Study ID Numbers: TQXB-R-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No