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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
248
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
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.
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.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Complete response rate during the overall phase
The proportion of patients without emesis episodes or rescue medication use during the overall phase (0-120 h)
Time frame: Up to 1-2 months
Complete response rate in the acute phase
The proportion of patients without emesis episodes or rescue medication use during the acute phase (0-24h)
Time frame: Up to 1-2 months
Complete response rate in the delayed phase
The proportion of patients without emesis episodes or rescue medication use during the delayed phase (25-120 h)
Time frame: Up to 1-2 months
No vomiting rate in the acute phase, delayed phase and overall phase
The proportion of no vomiting (no vomiting or retching episodes) in the acute phase, delayed phase and overall phase
Time frame: Up to 1-2 months
Affection caused by CINV reported by patients
Time frame: Up to 1-2 months
Effects of CINV on daily life
Time frame: Up to 1-2 months
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In the current clinical trial, placebo oral tablet is provided as a substance for Aprepitant with no active therapeutic effect.