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Trial Title:
Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients
NCT ID:
NCT06007586
Condition:
Gynecological Tumor
Conditions: Official terms:
Neoplasms
Aprepitant
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Care Provider, Investigator)
Masking description:
Patients, nurses, and investigators were blinded.
Intervention:
Intervention type:
Drug
Intervention name:
Aprepitant Injection
Description:
Two antiemetic groups use placebo,Dexamethasone and Ondansetron, Three antiemetic groups
use Aprepitant,Dexamethasone and Ondansetron.
Arm group label:
Three antiemetic group
Arm group label:
Two antiemetic groups
Other name:
Oribe
Summary:
To determine the best method to prevent CINV caused by TC regimen in patients with
gynecological malignant tumor.
Detailed description:
The risk of vomiting caused by high-dose carboplatin is controversial, and there is
currently no prevention of TC in patients with gynecological malignant tumors High-level
evidence-based medical evidence for programme-induced CINV. Therefore, different
guidelines recommend the best antiemetic regimen as well It's different. This study is
intended to conduct a prospective, multicenter, randomized, double-blind,
placebo-controlled, crossover study The designed Phase III clinical study provides
important data and basis for clinical practice and guideline formulation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 20-75 years old;
2. ECOG PS：0～2;
3. She was diagnosed as gynecological malignant tumor and was to receive TC
chemotherapy;
4. Carboplatin AUC 5～6mg/ml/min；
5. Basically normal organ function (normal bilirubin level circumference, normal range
of creatinine, ALT< 2 times the upper limit of normal, AST< 2 times the upper
normal value)
Exclusion Criteria:
1. Patients with previous history of chemotherapy, radiotherapy or targeted therapy;
2. Malignant tumors with brain metastases;
3. History of gastrointestinal malignancy;
4. History of brain tumor;
5. Previous gastrointestinal surgery history, such as segmental resection, (partial)
gastrectomy, except intestinal polyp resection and appendectomy;
6. (incomplete) intestinal obstruction;
7. Vestibular dysfunction;
8. Massive abdominal accumulation liquid (except for those who have undergone puncture
drainage);
9. Opioid concomitant drug users;
10. Diabetic.
Gender:
Female
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dengfeng Wang
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wang Dengfeng, Doctor
Phone:
15982222707
Email:
wonderful_96@163.com
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Wang Dengfeng
Start date:
May 28, 2024
Completion date:
February 10, 2025
Lead sponsor:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Source:
Sichuan Cancer Hospital and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06007586
