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Trial Title:
The Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV
NCT ID:
NCT05690802
Condition:
Nausea and Vomiting
Conditions: Official terms:
Nausea
Vomiting
Palonosetron
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Palonosetron hydrochloride capsules
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Palonosetron hydrochloride capsules
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.
Arm group label:
Palonosetron hydrochloride capsules
Other name:
Ruoshan ®
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital, the Air Force Medical University
Address:
City:
Xi'an
Zip:
710032
Country:
China
Status:
Recruiting
Contact:
Last name:
Liu Hong, master
Phone:
13709284513
Email:
hongliu1@fmmu.edu.cn
Start date:
May 16, 2022
Completion date:
May 30, 2029
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05690802
