Nausea and Vomiting Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 184 |
Est. completion date | December 29, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age =18 years, gender is not limited; 2. Histologically or cytologically confirmed diagnosis of malignant solid tumor; 3. 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 4. Nausea and vomiting prophylaxis with a triple regimen of fosaprepitant + ondansetron orally dissolved membrane + dexamethasone started before chemotherapy; 5. Expected survival = 3 months; 6. Eastern Cooperative Oncology Group (ECOG) physical status score =2; 7. Patients were able to read, understand, and complete study questionnaires; 8. Patients understood the study procedures and signed a written informed consent form Exclusion Criteria: 1. Patients scheduled to receive multiple days of highly emetogenic chemotherapy within one week; 2. 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; 3. Symptoms such as vomiting prior to randomization; 4. Patients on opioid therapy (except stable dose administration); 5. Patients treated with a chemotherapy regimen containing generic paclitaxel (using castor oil as a solvent); 6. 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; 7. Patients with active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) other than malignancy; 8. The patient has participated in another clinical trial within the past 4 weeks; 9. 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; 10. Pregnant or lactating females; 11. Presence of allergic conditions or prior serious adverse reactions to the study drug and excipients; 12. Suffering from psychological, familial, social, or geographic conditions that may prevent compliance with the study protocol and follow-up schedule; |
Country | Name | City | State |
---|---|---|---|
China | Keya Zhi | Weihui | None Selected |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Xinxiang Medical College |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of adverse events and serious adverse reactions throughout the study period | Record the incidence of adverse events and serious adverse reactions throughout the study period, focusing on events such as constipation and headache, which are common with antiemetics | 21 days | |
Primary | Incidence and severity of delayed vomiting in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups | The incidence of delayed vomiting was recorded and the severity of delayed vomiting was assessed by the VAS scale. | 21 days | |
Secondary | Incidence and severity of delayed nauseating in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups | The incidence of delayed nauseating was recorded and the severity of delayed nauseating was assessed by the VAS scale. | 21 days | |
Secondary | Incidence and severity of nausea/vomiting in patients on days 1-4 after chemotherapy in both groups | The incidence of delayed nausea/vomiting was recorded and the severity of delayed nausea/vomiting was assessed by the VAS scale. | 4 days |
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