the Efficacy and Safety of Ondansetron Oral Soluble Pellicles
The name of this prospective study is a multicenter, open-label, randomized controlled clinical study of the efficacy and safety of Ondansetron Oral Soluble Pellicles for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy.
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years, gender is not limited; Histologically or cytologically confirmed diagnosis of malignant solid tumor; Initial highly emetogenic one-day chemotherapy regimen (cisplatin dose 60-75 mg/m2; anthracycline compound adriamycin ≥ 60 mg/m2 or epothilone ≥ 90 mg/m2 ); and Nausea and vomiting prophylaxis with a triple regimen of fosaprepitant + ondansetron orally dissolved membrane + dexamethasone started before chemotherapy; Expected survival ≥ 3 months; Eastern Cooperative Oncology Group (ECOG) physical status score ≤2; Patients were able to read, understand, and complete study questionnaires; Patients understood the study procedures and signed a written informed consent form  Exclusion Criteria:  Patients scheduled to receive multiple days of highly emetogenic chemotherapy within one week; Patients using an antiemetic drug other than the study drug or a drug with an antiemetic active ingredient within 48 h prior to initiation of randomization and/or within one week of enrollment; Symptoms such as vomiting prior to randomization; Patients on opioid therapy (except stable dose administration); Patients treated with a chemotherapy regimen containing generic paclitaxel (using castor oil as a solvent); Patients who have received, or are expected to receive, radiotherapy to the abdomen (including the diaphragmatic plane and below) or pelvis within 1 week before randomization or one week after enrollment; Patients with active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) other than malignancy; The patient has participated in another clinical trial within the past 4 weeks; Any condition that, in the judgment of the investigator, is unstable or may jeopardize the safety of the subject and his or her compliance with the study; Pregnant or lactating females; Presence of allergic conditions or prior serious adverse reactions to the study drug and excipients; Suffering from psychological, familial, social, or geographic conditions that may prevent compliance with the study protocol and follow-up schedule; - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult