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

Nausea and Vomiting Clinical Trial

— TSEPHCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05690802
• Other study ID #: TQXB-R-001
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: May 30, 2029

Study information

• Verified date: January 2023
• Source: Xijing Hospital
• Contact: Liu Hong, master
• Phone: 13709284513
• Email: hongliu1[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1060
• Est. completion date: May 30, 2029
• Est. primary completion date: May 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, the Air Force Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any adverse event after treatment		1 year