Evaluating Palonosetron Hydrochloride Capsules for Preventing Nausea and Vomiting from Chemotherapy

Palonosetron Hydrochloride Capsules (Ruoshan ®) Used to Prevent and Control Chemotherapy for Tumor Patients Real World Study on the Safety of Nausea and Vomiting Reduction

This study tests if Palonosetron hydrochloride capsules can help cancer patients avoid nausea and vomiting from chemotherapy better than traditional IV treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1060 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xijing Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Xi'an, Shaan'xi)
• Trial ID: NCT05690802 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of Palonosetron hydrochloride capsules in preventing acute nausea and vomiting caused by moderate emetic chemotherapy. It focuses on patients with malignant tumors undergoing chemotherapy and analyzes the clinical benefits and characteristics of the population receiving this oral medication. The study will compare the oral administration of this antiemetic to traditional intravenous methods, emphasizing the convenience of oral therapy for both clinicians and patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with malignant tumors who are scheduled to receive moderate-risk chemotherapy and have a KPS score of 70 or higher.

Not a fit: Patients with contraindications to chemotherapy, severe heart or kidney disease, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients undergoing chemotherapy by effectively managing nausea and vomiting.

How similar studies have performed: Previous studies have shown that oral 5-HT3 receptor antagonists are effective in managing chemotherapy-induced nausea and vomiting, suggesting a positive outlook for this approach.

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.

Where this trial is running

Xi'an, Shaan'xi

• The First Affiliated Hospital, the Air Force Medical University — Xi'an, Shaan'xi, China (RECRUITING)

Study contacts

• Study coordinator: Liu Hong, master

Conditions: Nausea and Vomiting