Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Gynecological Tumor, Ovarian Cancer
Conditions
Keywords
Gynecologic Cancer, chemotherapy-induced nausea and vomiting, Paclitaxel-carboplatin
Brief 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.
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. In this prospective, multicenter, double-blind, placebo-controlled, crossover phase III trial, patients with gynecologic malignancies scheduled for at least two cycles of TC were randomly assigned to receive aprepitant or placebo with ondansetron and dexamethasone during cycle 1, crossing over to the alternate regimen in cycle 2. The primary endpoint was complete response (CR: no emesis, no significant nausea and no rescue therapy) in the delayed phase (24-168 hours). Secondary endpoints included CR in acute and overall phases, nausea severity, rescue medication use, adverse events, and patient satisfaction.
Interventions
Two antiemetic groups use placebo, dexamethasone and ondansetron. Three antiemetic groups use aprepitant, dexamethasone and ondansetron.
Sponsors
the Norman Bethune's Research Wing Promotion-Supporting Research Projects
Peking Union Medical College Hospital Talent Cultivation Program
Medical High Level Talents Program
Qilu Pharmaceutical Co., Ltd.
Sichuan Cancer Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Both patients and investigators, including follow-up staff, were blinded to treatment allocation.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Eligibility criteria: histologically confirmed gynecologic malignancies (including newly diagnosed cases and recurrent cases without chemo- or radiotherapy within the past six months); age 20-75 years; ECOG performance status 0-2; scheduled to receive at least two cycles of paclitaxel (175 mg/m²) plus carboplatin (AUC 5-6) every 3 weeks; and adequate organ function (bilirubin and creatinine within normal range, ALT and AST \< 2× upper limit of normal).
Exclusion criteria
included prior chemotherapy, radiotherapy, or targeted therapy for the current recurrence; known brain metastases or history of brain tumors; history of gastrointestinal malignancy or major gastrointestinal surgery (except polypectomy or appendectomy); incomplete bowel obstruction; vestibular dysfunction; massive ascites (unless drained); concomitant opioid use; or diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response (CR) rate in the delayed period | 24 hours to 7days after chemotherapy (each cycle is 21 days) | CR is defined as no emesis, no significant nausea (VAS ≤4, where 0 = none, 10= = most severe), and no use of rescue antiemetics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CR rates in the acute phase (0-24 hours) and overall phase (0-7 days). | acute phase: within 24 hours after chemotherapy (each cycle is 21 days); overall phase: within 7 days after chemotherapy (each cycle is 21 days). | CR rates in the acute phase (0-24 hours) and overall phase (0-7 days). |
| the use of rescue antiemetic | within 7 days after chemotherapy (each cycle is 21 days). | the use of rescue antiemetic (0-7 days) |
| patient satisfaction | On day 7 and 14 of each cycle (each cycle is 21 days). | patient satisfaction assessed with a 7-point Likert-type scale (1=Very dissatisfied; 2=dissatisfied; 3=Relatively dissatisfied; 4=quite satisfied; 5=somewhat satisfied; 6=Satisfied; 7=Very satisfied) |
| AEs | within 7 days after chemotherapy (each cycle is 21 days). | incidence of adverse events |
| severity of nausea | within 7 days after chemotherapy (each cycle is 21 days). | severity of nausea (VAS: 0 = none, 10 = most severe) |
Countries
China
Outcome results
None listed