Back to resultsThe Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV (TSEPHCC)
Primary Purpose
Nausea and Vomiting
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Palonosetron hydrochloride capsules
Sponsored by
About this trial
This is an interventional treatment trial for Nausea and Vomiting
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated Hospital, the Air Force Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Palonosetron hydrochloride capsules
Arm Description
The recommended dose for adults is 0.5mg (1 capsule) for a single oral dose about 1 hour before chemotherapy.
Outcomes
Primary Outcome Measures
Any adverse event after treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05690802
Brief Title
The Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
May 30, 2027 (Anticipated)
Study Completion Date
May 30, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Palonosetron hydrochloride capsules
Masking
None (Open Label)
Allocation
N/A
Enrollment
1060 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Palonosetron hydrochloride capsules
Arm Type
Experimental
Arm Description
The recommended dose for adults is 0.5mg (1 capsule) for a single oral dose about 1 hour before chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Palonosetron hydrochloride capsules
Other Intervention Name(s)
Ruoshan ®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Any adverse event after treatment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Hong, master
Phone
13709284513
Email
hongliu1@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zhou, master
Phone
13720542643
Email
252376698@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Hong, master
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital, the Air Force Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Hong, master
Phone
13709284513
Email
hongliu1@fmmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
The Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV
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