NCT03674294

Aprepitant Triple Therapy for the Prevention of CINV in Nondrinking and Young Women Who Received Moderately Emetogenic Chemotherapy

Efficacy of Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Nondrinking Women Younger Than 50 Years Who Received Moderately Emetogenic Chemotherapy: A Randomized, Double-blind, Phase Ⅲ Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to study whether adding Aprepitant to Palonosetron and dexamethasone can further prevent the incidence and severity of nausea and vomiting caused by FOLFIRI or FOLFOX chemotherapy regimen among gastrointestinal malignancy patients with high risk factors of chemotherapy-associated adverse events.

Detailed description

The purpose of this study is to study whether adding Aprepitant to Palonosetron and dexamethasone can further prevent the incidence and severity of nausea and vomiting caused by FOLFIRI or FOLFOX chemotherapy regimen after curative effect among gastrointestinal malignancy patients with high risk factors of chemotherapy-associated adverse events.This study will observe and evaluate the incidence and severity of nausea and vomiting as well as the effectiveness of corresponding treatment(with or without Aprepitant) during Day 1 to Day 5 from the beginning of chemotherapy.

Conditions

• Gastrointestinal Neoplasms
• Chemotherapy-induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Aprepitant	Aprepitant is manufactured by Merck \& Co. for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) and for prevention of postoperative nausea and vomiting. It was approved by the FDA in 2003
DRUG	Palonosetron	Palonosetron is a 5-HT3 antagonist used in the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). It is used for the control of delayed CINV-nausea and vomiting and there are tentative data to suggest that it may be more effective than granisetron.
DRUG	Dexamethasone	Dexamethasone is a type of corticosteroid medication. It is used in the treatment of many conditions, including rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive lung disease, croup, brain swelling, and along with antibiotics in tuberculosis.
DRUG	Placebo Oral Tablet	In the current clinical trial, placebo oral tablet is provided as a substance for Aprepitant with no active therapeutic effect.

Timeline

• Start date: 2015-08-04
• Primary completion: 2020-03-31
• Completion: 2020-06-01
• First posted: 2018-09-17
• Last updated: 2023-02-08

Locations

1 site across 1 country: China