Clinical trial · Interventional
The Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV
Palonosetron Hydrochloride Capsules (Ruoshan ®) Used to Prevent and Control Chemotherapy for Tumor Patients Real World Study on the Safety of Nausea and Vomiting Reduction
NCT05690802CI-TRIAL-00063311TSEPHCCrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palonosetron hydrochloride capsules | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Palonosetron hydrochloride capsules
- description
- The recommended dose for adults is 0.5mg (1 capsule) for a single oral dose about 1 hour before chemotherapy.
- interventionNames
- Drug: Palonosetron hydrochloride capsules
Primary outcomes (1)
- measure
- Any adverse event after treatment
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.