Preventing and treating nausea from chemotherapy in gynecological cancer patients
A Randomized, Double-blind, Placebo-controlled Clinical Study on Prevention and Treatment of CINV Induced by TC Regimen in Gynecological Malignant Tumors
This study is testing if a medication called Aprepitant can help prevent nausea and vomiting in women with gynecological cancer who are receiving chemotherapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | Female |
| Sponsor | Sichuan Cancer Hospital and Research Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Chengdu, Sichua and 1 other locations) |
| Trial ID | NCT06007586 on ClinicalTrials.gov |
What this trial studies
This study aims to identify the most effective method for preventing chemotherapy-induced nausea and vomiting (CINV) in patients with gynecological malignant tumors undergoing TC chemotherapy. It will utilize a multicenter, randomized, double-blind, placebo-controlled, crossover design to evaluate the efficacy of Aprepitant Injection. The study seeks to provide high-level evidence to inform clinical practice and guideline formulation regarding CINV management in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 20-75 with a diagnosis of gynecological malignant tumors who are scheduled to receive TC chemotherapy.
Not a fit: Patients with a history of chemotherapy, radiotherapy, or targeted therapy, as well as those with certain gastrointestinal or brain conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients undergoing chemotherapy by effectively managing nausea and vomiting.
How similar studies have performed: Other studies have shown varying success in managing CINV with different antiemetic regimens, but this specific approach in gynecological cancer patients is less explored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chengdu, Sichua and 1 other locations
- Dengfeng Wang — Chengdu, Sichua, China (Not_yet_recruiting)
- Sichuan Cancer Hospital — Chengdu, China (Recruiting)
Study contacts
- Study coordinator: Dengfeng Wang
- Email: wonderful_96@163.com
- Phone: 15982222707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.