Thyroid CancerPhase 4NCT06697782
Aprepitant and Ondansetron Monotherapy or Combination for Postoperative Nausea and Vomiting in Thyroid Cancer
A Phase 4 study testing Ondansetron 8mg and Aprepitant 125 mg in people with Thyroid Cancer, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Ondansetron 8mg and Aprepitant 125 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years;
- Voluntary enrollment in the study and signing the informed consent form;
- Diagnosed with thyroid cancer and needing surgical treatment;
Who cannot join
- Patient has depression, history of chronic pain, insulin-dependent diabetes mellitus I or II, history of severe vomiting;
- history of prior thyroid or neck surgery;
- Cases in which surgery requiring sternotomy is anticipated;
- History of long-term hormone use, period of immunosuppressive therapy;
- pre-operative voice changes or laryngoscopic confirmation of vocal cord paralysis;
- Pregnant or breastfeeding patients;
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- Patients who are allergic to any of the study medications;
- 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;
- patients with other malignant tumors;
- Patients with hypothyroidism;
- Participating or planning to participate in other clinical studies.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: Clinical Study of Aprepitant and Ondansetron Monotherapy or Combination in the Treatment of Postoperative Nausea and Vomiting in Thyroid Carcinoma
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.
Read the 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.
- Conditions
- Thyroid Cancer
- Being tested
- Ondansetron 8mg, Aprepitant 125 mg
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 8mgDrug
Also called AD
Patients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter
Aprepitant 125 mgDrug
Also called AR
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)
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron group | Other | Patients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter Receives: Drug: Ondansetron 8mg |
| Arepitant group | Other | 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) Receives: Drug: Aprepitant 125 mg |
| Combined treatment group | Experimental | 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) Receives: Drug: Ondansetron 8mg; Drug: Aprepitant 125 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate (CR rate)
Complete remission rate (CR rate) without vomiting within 24h postoperatively and without resolution
Measured: Within 24 hours after surgery
Secondary outcomes (3)
Complete remission rate (CR rate)
Complete remission rate (CR rate) without vomiting within 48h postoperatively and without resolution
Measured: Within 48 hours after surgery
Rate of no vomiting
Rate of no vomiting within 24h, 48h
Measured: Within 24 and 48 hours after surgery
Incidence of adverse events and serious adverse events
Adverse events and serious adverse events
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Jul 2024
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shumin Dong, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Detao Yin, M.D., Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697782
- Sponsor's protocol ID
- HN-PONV-ADR-01
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Aprepitant and Ondansetron Monotherapy or Combination in the Treatment of Postoperative Nausea and Vomiting in Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT06697782
- Acronym / sponsor ID
- HN-PONV-ADR-01
- Conditions
- Thyroid Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ondansetron group | Other | Drug: Ondansetron 8mgPatients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter |
| Arepitant group | Other | Drug: Aprepitant 125 mgPatients 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 | Experimental | Drug: Ondansetron 8mg, Drug: Aprepitant 125 mgPatients 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-80 years;
- Voluntary enrollment in the study and signing the informed consent form;
- Diagnosed with thyroid cancer and needing surgical treatment;
Key exclusion criteria (12 listed)
- Patient has depression, history of chronic pain, insulin-dependent diabetes mellitus I or II, history of severe vomiting;
- history of prior thyroid or neck surgery;
- Cases in which surgery requiring sternotomy is anticipated;
- History of long-term hormone use, period of immunosuppressive therapy;
- pre-operative voice changes or laryngoscopic confirmation of vocal cord paralysis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetron 8mgAlso: ADPatients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter | Drug | Combined treatment group, Ondansetron group |
| Aprepitant 125 mgAlso: ARPatients 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) | Drug | Arepitant group, Combined treatment group |
Primary outcome
Complete remission rate (CR rate)
Time frame: Within 24 hours after surgery
Complete remission rate (CR rate) without vomiting within 24h postoperatively and without resolution
3 secondary outcomes
Complete remission rate (CR rate)
Time frame: Within 48 hours after surgery
Rate of no vomiting
Time frame: Within 24 and 48 hours after surgery
Incidence of adverse events and serious adverse events
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Detao Yin, M.D. principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron 8mg and Aprepitant 125 mg in people with Thyroid Cancer, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate (CR rate) (time frame: Within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.