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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Any adverse event after treatment [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital, the Air Force Medical University — Сиань

Идентификаторы

NCT: NCT05690802 · TQXB-R-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗