A Randomized, Double-blind, Placebo-controlled Clinical Study on Prevention and Treatment of CINV Induced by TC Regimen in Gynecological Malignant Tumors
Overview
- Phase
- Phase 3
- Intervention
- Aprepitant Injection
- Conditions
- Not specified
- Sponsor
- Sichuan Cancer Hospital and Research Institute
- Enrollment
- 143
- Locations
- 2
- Primary Endpoint
- Complete response (CR) rate in the delayed period
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Dengfeng Wang
Deputy chief
Sichuan Cancer Hospital and Research Institute
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group A
patients in group A received the two-drug antiemetic regimen (placebo cycle) during the first cycle followed by the three-drug regimen (aprepitant cycle) during the second cycle. The two-drug regimen (placebo cycle) consisted of intravenous placebo 130 mg, intravenous ondansetron 8 mg, and intravenous dexamethasone 12 mg, all administered 30 minutes before chemotherapy on day 1, followed by oral dexamethasone 8 mg once daily on days 2-4. The three-drug regimen (aprepitant cycle) replaced placebo with intravenous aprepitant 130 mg on day 1, with all other medications administered as in the two-drug regime
Intervention: Aprepitant Injection
Group B
patients in group B received the regimens in the reverse order. The three-drug regimen (aprepitant cycle) replaced placebo with intravenous aprepitant 130 mg on day 1, with all other medications administered as in the two-drug regime. The two-drug regimen (placebo cycle) consisted of intravenous placebo 130 mg, intravenous ondansetron 8 mg, and intravenous dexamethasone 12 mg, all administered 30 minutes before chemotherapy on day 1, followed by oral dexamethasone 8 mg once daily on days 2-4.
Intervention: Aprepitant Injection
Outcomes
Primary Outcomes
Complete response (CR) rate in the delayed period
Time Frame: 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 Outcomes
- 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).)
- the use of rescue antiemetic(within 7 days after chemotherapy (each cycle is 21 days).)
- patient satisfaction(On day 7 and 14 of each cycle (each cycle is 21 days).)
- AEs(within 7 days after chemotherapy (each cycle is 21 days).)
- severity of nausea(within 7 days after chemotherapy (each cycle is 21 days).)