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

Sponsor
Xijing Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05690802
Collaborator
(none)
1,060
Enrollment
1
Location
1
Arm
84.5
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Palonosetron hydrochloride capsules
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1060 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Palonosetron hydrochloride capsulesPalonosetron hydrochloride capsules
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 16, 2022
Anticipated Primary Completion Date :
May 30, 2027
Anticipated Study Completion Date :
May 30, 2029

Arms and Interventions

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 ®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Any adverse event after treatment [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital, the Air Force Medical University Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • Xijing Hospital

    Investigators

    • Study Chair: Liu Hong, master, Air Force Military Medical University, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xijing Hospital
    ClinicalTrials.gov Identifier:
    NCT05690802
    Other Study ID Numbers:
    • TQXB-R-001
    First Posted:
    Jan 19, 2023
    Last Update Posted:
    Jan 19, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Nausea
    Vomiting
    Palonosetron

    Study Results

    No Results Posted as of Jan 19, 2023