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Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients

NCT06007586 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2025-12-04

No results posted yet for this study

Summary

To determine the best method to prevent CINV caused by TC regimen in patients with gynecological malignant tumor.

Paclitaxel-carboplatin (TC) is the most widely used regimen for gynecologic malignancies, yet chemotherapy-induced nausea and vomiting (CINV) remain common and distressing. Optimal prophylaxis is uncertain. This trial evaluated whether adding the NK1 receptor antagonist aprepitant to standard two-drug prophylaxis (5-HT3 receptor antagonist plus dexamethasone) improves CINV control.

Conditions

Interventions

DRUG

Aprepitant Injection

Two antiemetic groups use placebo, dexamethasone and ondansetron. Three antiemetic groups use aprepitant, dexamethasone and ondansetron.

Sponsors & Collaborators

  • the Norman Bethune's "Research Wing Promotion"-Supporting Research Projects

    collaborator UNKNOWN

  • Peking Union Medical College Hospital Talent Cultivation Program

    collaborator UNKNOWN

  • Medical High Level Talents Program

    collaborator UNKNOWN

  • Qilu Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sichuan Cancer Hospital and Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2025-06-20
Completion
2025-07-04

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06007586 on ClinicalTrials.gov