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

NCT06697782 | Completed Phase 4

• 1 other identifier: HN-PONV-ADR-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Complete remission rate (CR rate)

  Complete remission rate (CR rate) without vomiting within 24h postoperatively and without resolution

  Within 24 hours after surgery

Secondary Outcomes (3)

• Complete remission rate (CR rate)

  Within 48 hours after surgery

• Rate of no vomiting

  Within 24 and 48 hours after surgery

• Incidence of adverse events and serious adverse events

  up to 24 weeks

Study Arms (3)

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

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)

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)

Drug: Ondansetron 8mg; Drug: Aprepitant 125 mg

Interventions

Ondansetron 8mg DRUG

Patients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter

Also known as: AD

Combined treatment group; Ondansetron group

Aprepitant 125 mg DRUG

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)

Also known as: AR

Arepitant group; Combined treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Ondansetron; Aprepitant

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Morpholines; Oxazines

Study Officials

• Detao Yin, M.D.

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)