A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy for Lung Cancer Using Rolapitant and Palonosetron

Korábbi kezelés

• Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, dexamethasone, or olanzapine;
• Vomiting symptoms (≥1 episode/day) or VAS score ≥30 mm within 7 days prior to first administration;
• Use of medications with potential antiemetic effects within 2 days prior to first dose: first-generation 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, secloperazine, etc.;
• Currently participating in another interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose (subjects who failed screening for another clinical trial may be included in this study);

Más betegség

• Patients with a documented history of severe hypersensitivity to the active ingredient or excipients of the drug.
• Presence of conditions affecting vomiting assessment, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction;
• History of epilepsy or current use of antiepileptic drugs;
• History of severe psychiatric disorders, substance abuse, alcoholism, or drug addiction;
• Presence of any other factors deemed by the investigator to increase study risk, compromise patient compliance with the protocol, or affect the patient's ability to complete the trial, such as physiological or psychological conditions;

Egyéb

• Patients with imaging-confirmed brain metastases accompanied by symptoms of increased intracranial pressure (e.g., headache, vomiting, papilledema) or objective evidence of elevated intracranial pressure.
• Pregnant or lactating women;

• Age ≥18 years, no gender restrictions;
• Histopathologically or cytologically confirmed lung cancer;
• Planned to receive concurrent chemoradiotherapy for at least 6 weeks, with radiotherapy administered in conventional fractions (2.0-2.2 Gy/fraction, 5 fractions/week, total dose 60-66 Gy); chemotherapy regimen includes highly emetogenic agents (e.g., cisplatin ≥60 mg/m²) ;
• ECOG Performance Status score: 0-1;
• Expected survival >12 weeks;
• Adequate organ and bone marrow function;
• Willingness to complete daily nausea/vomiting logs and scale assessments.