Aprepitant and Ondansetron Monotherapy or Combination for Postoperative Nausea and Vomiting in Thyroid Cancer

Phase 4

Completed

• Conditions: Thyroid Cancer
• Interventions: Drug: Ondansetron 8mg; Drug: Aprepitant 125 mg

• Registration Number: NCT06697782
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

Brief Summary

The vast majority of patients treated prophylactically with "first-line" antiemetics in the 5-hydroxytryptamine (5-HT3) receptor antagonist class still have significant PONV. Combination therapies with different pharmacologic bases have the potential to reduce the incidence of PONV. This study is a multicenter, three-arm, prospective study to evaluate the efficacy and safety of aprepitant and ondansetron, monotherapy or in combination, in the prevention of nausea and vomiting after surgery for thyroid cancer.

Detailed Description

Postoperative nausea and vomiting (PONV) is the most common complication after surgery, especially thyroidectomy, and the incidence of PONV can be as high as 80% without the administration of prophylactic antiemetics. Currently, available prophylactic interventions for PONV, especially monotherapy, lack universal efficacy. Combination therapy with a different pharmacologic basis has the potential to reduce the incidence of PONV. Previous studies using various 5-HT3 receptor antagonists in combination with aprepitant have shown promising results in reducing the incidence of PONV. The present study is a multicenter, three-arm, prospective study designed to evaluate the efficacy and safety of aprepitant and ondansetron, alone or in combination, in the prevention of postoperative nausea and vomiting in thyroid cancer.

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-20
• Primary Completion: 2024-12-01
• Study Completion: 2025-01-01
• Last Update Submitted: 2025-01-18
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Patients aged 18-80 years;
2. Voluntary enrollment in the study and signing the informed consent form;
3. Diagnosed with thyroid cancer and needing surgical treatment;

Exclusion Criteria

1. Patient has depression, history of chronic pain, insulin-dependent diabetes mellitus I or II, history of severe vomiting;
2. history of prior thyroid or neck surgery;
3. Cases in which surgery requiring sternotomy is anticipated;
4. History of long-term hormone use, period of immunosuppressive therapy;
5. pre-operative voice changes or laryngoscopic confirmation of vocal cord paralysis;
6. Pregnant or breastfeeding patients;
7. Patients who are allergic to any of the study medications;
8. Patients who have received any sedative, hypnotic, anxiolytic, opioid, steroid or other antiemetic medication within 24 hours prior to the procedure;
9. Patients taking or planning to take a combination of drugs such as rifampicin, carbamazepine, phenytoin or other drugs that strongly induce CYP3A4 activity;
10. patients with other malignant tumors;
11. Patients with hypothyroidism;
12. Participating or planning to participate in other clinical studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ondansetron group	Ondansetron 8mg	Patients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter
Arepitant group	Aprepitant 125 mg	Patients in the aprepitant group received 125 mg of aprepitant orally 1 hour before anesthesia and 80 mg orally once daily in the morning of postoperative days 2 and 3 (the day of the surgery was day 1)
Combined treatment group	Ondansetron 8mg	Patients in the combined group received 125 mg of oral aprepitant plus 8 mg of ondansetron 1 hour before anesthesia, with ondansetron followed by two oral doses of the drug at 8-hour intervals, and 80 mg of aprepitant once daily in the morning on postoperative days 2 and 3 (the day of the surgery was day 1)
Combined treatment group	Aprepitant 125 mg	Patients in the combined group received 125 mg of oral aprepitant plus 8 mg of ondansetron 1 hour before anesthesia, with ondansetron followed by two oral doses of the drug at 8-hour intervals, and 80 mg of aprepitant once daily in the morning on postoperative days 2 and 3 (the day of the surgery was day 1)

Primary Outcome Measures

Name	Time	Method
Complete remission rate (CR rate)	Within 24 hours after surgery	Complete remission rate (CR rate) without vomiting within 24h postoperatively and without resolution

Secondary Outcome Measures

Name	Time	Method
Complete remission rate (CR rate)	Within 48 hours after surgery	Complete remission rate (CR rate) without vomiting within 48h postoperatively and without resolution
Rate of no vomiting	Within 24 and 48 hours after surgery	Rate of no vomiting within 24h, 48h
Incidence of adverse events and serious adverse events	up to 24 weeks	Adverse events and serious adverse events

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China