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

NCT05690802 | Recruiting DMC

• 1 other identifier: TQXB-R-001
• Study Type: interventional
• Target: 1,060
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Any adverse event after treatment

  1 year

Study Arms (1)

Palonosetron hydrochloride capsules

EXPERIMENTAL

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

Drug: Palonosetron hydrochloride capsules

Interventions

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.

Also known as: Ruoshan ®

Palonosetron hydrochloride capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affiliated Hospital, the Air Force Medical University

Xi'an, Shaan'xi, 710032, China

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Liu Hong, master

  Air Force Military Medical University, China

  STUDY CHAIR

Central Study Contacts

Liu Hong, master

CONTACT

13709284513; hongliu1@fmmu.edu.cn

Wei Zhou, master

CONTACT

13720542643; 252376698@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Palonosetron hydrochloride capsules

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: May 16, 2022
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2029
• Last Updated: January 19, 2023

Record last verified: 2023-01

Locations

CN (1)