the Efficacy and Safety of Ondansetron Oral Soluble Pellicles

Launched by THE FIRST AFFILIATED HOSPITAL OF XINXIANG MEDICAL COLLEGE · Feb 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Ondansetron Oral Soluble Pellicles to see how well it works in preventing nausea and vomiting that can happen after certain types of chemotherapy. The trial is specifically looking at patients who are undergoing a strong chemotherapy treatment for solid tumors. To be eligible, participants need to be at least 18 years old, have a confirmed diagnosis of cancer, and be starting a specific one-day chemotherapy regimen that is known to cause nausea. They should also be able to understand and complete study questionnaires.

Participants in the trial can expect to take the Ondansetron medication along with a few other drugs before their chemotherapy to help prevent nausea and vomiting. The study is currently recruiting participants of all genders and aims to ensure their safety and well-being throughout the process. It’s important to note that certain patients, such as those with active infections or those who are pregnant, may not be eligible to join. Overall, this trial aims to provide more effective ways to manage nausea and vomiting for patients undergoing chemotherapy.

Gender

ALL

Eligibility criteria

• 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;