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To Determine the Best Method to Prevent CINV Caused by TC Regimen in Patients With Gynecological Malignant Tumor.

Sponsor
Sichuan Cancer Hospital and Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06007586
Collaborator
(none)
138
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
11.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Aprepitant Injection
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Patients, nurses, and investigators were blinded.
Primary Purpose:
Prevention
Official Title:
To Determine the Best Method to Prevent CINV Caused by TC Regimen in Patients With Gynecological Malignant Tumor.
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Two antiemetic groups

Placebo 130mg iv d1 30min d1 before chemotherapy (IV time > 2min);Ondansetron 8mg iv once d1 30min before chemotherapy; Dexamethasone 12mg iv once d1 before chemotherapy 30min, dexamethasone 8mg po qd d2 ~ 4.

Drug: Aprepitant Injection
Two antiemetic groups use placebo,Dexamethasone and Ondansetron, Three antiemetic groups use Aprepitant,Dexamethasone and Ondansetron.
Other Names:
  • Random

    		•
    Experimental: Three antiemetic group

    Aprepitant injection 130mg iv d1 30min d1 before chemotherapy (push-back time > 2min);Ondansetron 8mg iv once d1 30min before chemotherapy;Dexamethasone 12mg iv once d1 30min before chemotherapy, 8mg po qd d2-4.

    Drug: Aprepitant Injection
    Two antiemetic groups use placebo,Dexamethasone and Ondansetron, Three antiemetic groups use Aprepitant,Dexamethasone and Ondansetron.
    Other Names:
  • Random

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complete response (CR) rate in the delayed period [24 hours to 7days]

      CR is defined as a patient who does not need rescue antiemesis treatment, no vomiting or retching.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dengfeng Wang Chengdu Sichua China 610041

    Sponsors and Collaborators

    • Sichuan Cancer Hospital and Research Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dengfeng Wang, Deputy chief, Sichuan Cancer Hospital and Research Institute
    ClinicalTrials.gov Identifier:
    NCT06007586
    Other Study ID Numbers:
    • CINV202306
    First Posted:
    Aug 23, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Aprepitant

    Study Results

    No Results Posted as of Aug 23, 2023