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

Phase 3

Completed

• Conditions: Gastrointestinal Neoplasms; Chemotherapy-induced Nausea and Vomiting
• Interventions: Drug: Aprepitant; Drug: Palonosetron; Drug: Placebo Oral Tablet; Drug: Dexamethasone

• Registration Number: NCT03674294
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Study Timeline

• Study Start: 2015-08-04
• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-17
• Primary Completion: 2020-03-31
• Study Completion: 2020-06-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 248

Inclusion Criteria

• Diagnosed by pathology as gastrointestinal carcinoma and no previous FOLFOX or FOLFIRI based regimen chemotherapy history.
• Female.
• Adult patients ( ≥ 18, ≤ 50 years of age)
• No long-term or excessive alcohol intake history:1.Alcohol intake less than 5 times per week; 2.Alcohol intake less than 100g per day.
• Performance status ECOG 0-1
• Adequate haematological, hepatic, renal and metabolic function parameters:

Leukocytes : 3,500-10,000/mm3, ANC ≥ 1,500/mm3, Platelets ≥ 90,000/mm3, Hb > 9g/dl (may be transfused or treated with erythropoietin to maintain or exceed this level), Serum creatinine ≤ 1 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal, Serum AST, ALT, ALP ≤ 2.5 x upper limit of normal in absence of liver metastases, or ≤ 5 x upper limit of normal in presence of liver metastases.

• Negative pregnancy test. If pregnancy test were positive, subject should be included in the trial only when the subsequent pregnancy test is negative.
• Ability of reading, comprehending and finishing trial questionnaires and record, including VAS (Visual Analogue Scale) question.
• Before subject registration, written informed consent must be given according to local regulations.

Exclusion Criteria

• Pregnant women without morning sickness.
• Presence of gastrointestinal tract obstruction or electrolyte imbalance.
• Any history of central nervous system disease(e.g. Primary brain tumour, seizure not controlled with standard medical therapy, brain metastases or history of stroke).
• Contraindication of glucocorticoid:1.Infection of virus, bacteria or fungus uncontrolled by antibiotics; 2.Active stomach or duodenum ulcer; 3.Severe hypertension, atherosclerosis, diabetes; 4.Osteoporosis;5.Corneal ulcer; 6.Pregnancy; 7.Reparative phase of trauma, operation or fraction; 8.Hypercortisolism; 9.Severe mental disorder or epilepsy; 10.Inadequate cardiac or renal function.
• Mental disability or severe emotional or mental disorder.
• Active infection(e.g. pneumonia, hepatitis) or any uncontrolled disease(e.g.diabetic ketoacidosis) that may affect study outcome or expose patients to unnecessary risk.
• Usage of any illicit drug, including medical marijuana or alcohol abusing(China drug dependence criteria).
• Treatment of unapproved medicine in the previous 4 weeks.
• Concomitant therapy of psychotropic medicine such as olanzapine.
• Hypersensitivity history towards Aprepitant, 5-HT3 receptor antagonist or dexamethasone.
• Previous treatment of Aprepitant.
• Unable to swallow capsules.
• Main researchers considered that the patient is unsuited to the trial.
• Unable or unwilling to follow research programme.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palonosetron/Dexamethasone/Aprepitant	Palonosetron	-
Palonosetron/Dexamethasone/Placebo	Placebo Oral Tablet	-
Palonosetron/Dexamethasone/Aprepitant	Aprepitant	-
Palonosetron/Dexamethasone/Aprepitant	Dexamethasone	-
Palonosetron/Dexamethasone/Placebo	Palonosetron	-
Palonosetron/Dexamethasone/Placebo	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Complete response rate during the overall phase	Up to 1-2 months	The proportion of patients without emesis episodes or rescue medication use during the overall phase (0-120 h)

Secondary Outcome Measures

Name	Time	Method
Complete response rate in the acute phase	Up to 1-2 months	The proportion of patients without emesis episodes or rescue medication use during the acute phase (0-24h)
No vomiting rate in the acute phase, delayed phase and overall phase	Up to 1-2 months	The proportion of no vomiting (no vomiting or retching episodes) in the acute phase, delayed phase and overall phase
Affection caused by CINV reported by patients	Up to 1-2 months
Complete response rate in the delayed phase	Up to 1-2 months	The proportion of patients without emesis episodes or rescue medication use during the delayed phase (25-120 h)
Effects of CINV on daily life	Up to 1-2 months

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China