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NCT06697782CompletedPhase 4

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

Clinical Study of Aprepitant and Ondansetron Monotherapy or Combination in the Treatment of Postoperative Nausea and Vomiting in Thyroid Carcinoma

Source: ClinicalTrials.gov · Last updated 22 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
600 (actual)
First submitted
18 Nov 2024
Start date
1 Jul 2024
Primary completion date
1 Dec 2024
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
NCT number
NCT06697782

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 600
  • From 1 Jul 2024 to the primary completion date, 1 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • history of prior thyroid or neck surgery;
  • Cases in which surgery requiring sternotomy is anticipated;
  • Patients who have received any sedative, hypnotic, anxiolytic, opioid, steroid or other antiemetic medication within 24 hours prior to the procedure;
  • Patients taking or planning to take a combination of drugs such as rifampicin, carbamazepine, phenytoin or other drugs that strongly induce CYP3A4 activity;

Other illness

  • Patient has depression, history of chronic pain, insulin-dependent diabetes mellitus I or II, history of severe vomiting;
  • History of long-term hormone use, period of immunosuppressive therapy;
  • Patients who are allergic to any of the study medications;
  • patients with other malignant tumors;

Other

  • pre-operative voice changes or laryngoscopic confirmation of vocal cord paralysis;
  • Pregnant or breastfeeding patients;
  • Patients with hypothyroidism;
  • Participating or planning to participate in other clinical studies.

Who the study is looking for

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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Zhengzhou University
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.