Clinical trial NCT06697782: Aprepitant and Ondansetron Monotherapy or Combination for Postoperative Nausea and Vomiting in Thyroid Cancer
Official title: Clinical Study of Aprepitant and Ondansetron Monotherapy or Combination in the Treatment of Postoperative Nausea and Vomiting in Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thyroid Cancer
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete remission rate (CR rate)
timeFrame: Within 24 hours after surgery
Secondary outcomes:
measure: Complete remission rate (CR rate)
timeFrame: Within 48 hours after surgery
measure: Rate of no vomiting
timeFrame: Within 24 and 48 hours after surgery
measure: Incidence of adverse events and serious adverse events
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Detao Yin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: