Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05690802

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, the Air Force Medical University

Xi'an, Shaan'xi, 710032, China

Location status: Recruiting

Location contact

Liu Hong, master

CONTACT

[email protected]

13709284513

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ruoshan ®

Primary outcomes

  1. Any adverse event after treatment

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Liu Hong, master

CONTACT

[email protected]

13709284513

Wei Zhou, master

CONTACT

[email protected]

13720542643

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study 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

Acronym: TSEPHCC

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Jan 19, 2023
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.