Efficacy and safety of Ondansetron Oral Soluble Pellicles for nausea and vomiting prevention

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

This study is testing if a new form of Ondansetron can help prevent nausea and vomiting in people getting strong chemotherapy for the first time.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Xinxiang Medical College (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Weihui, None Selected)
• Trial ID: NCT06282211 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, randomized controlled clinical study aims to evaluate the efficacy and safety of Ondansetron Oral Soluble Pellicles in preventing delayed nausea and vomiting caused by highly emetogenic chemotherapy. The study will enroll 184 patients undergoing their first highly emetogenic chemotherapy regimen, specifically those receiving cisplatin or anthracycline compounds. Participants will be randomized into two groups, with one receiving the Ondansetron treatment alongside a triple regimen of fosaprepitant and dexamethasone. The primary focus will be on the incidence and severity of delayed nausea and vomiting from day 5 after chemotherapy to the second cycle, along with monitoring adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of malignant solid tumors who are about to receive their first highly emetogenic chemotherapy.

Not a fit: Patients scheduled for multiple days of highly emetogenic chemotherapy within one week or those using other antiemetic drugs prior to the study may not benefit.

Why it matters

Potential benefit: If successful, this study could significantly improve the management of nausea and vomiting in patients undergoing chemotherapy, enhancing their quality of life.

How similar studies have performed: Previous studies have shown positive outcomes with similar antiemetic approaches, suggesting potential for success in this trial.

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;

Where this trial is running

Weihui, None Selected

• Keya Zhi — Weihui, None Selected, China (Recruiting)

Study contacts

• Study coordinator: Yinghua Ji

Conditions Nausea and Vomiting