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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Complete response rate during the overall phase
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed by pathology as gastrointestinal carcinoma and no previous FOLFOX or FOLFIRI based regimen chemotherapy history.
- •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.
排除标准
- •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.
研究组 & 干预措施
Palonosetron/Dexamethasone/Aprepitant
干预措施: Aprepitant (Drug)
Palonosetron/Dexamethasone/Aprepitant
干预措施: Palonosetron (Drug)
Palonosetron/Dexamethasone/Aprepitant
干预措施: Dexamethasone (Drug)
Palonosetron/Dexamethasone/Placebo
干预措施: Palonosetron (Drug)
Palonosetron/Dexamethasone/Placebo
干预措施: Dexamethasone (Drug)
Palonosetron/Dexamethasone/Placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Complete response rate during the overall phase
时间窗: Up to 1-2 months
The proportion of patients without emesis episodes or rescue medication use during the overall phase (0-120 h)
次要结局
- Complete response rate in the acute phase(Up to 1-2 months)
- No vomiting rate in the acute phase, delayed phase and overall phase(Up to 1-2 months)
- Affection caused by CINV reported by patients(Up to 1-2 months)
- Complete response rate in the delayed phase(Up to 1-2 months)
- Effects of CINV on daily life(Up to 1-2 months)
研究者
Yuhong Li
Director, Department of Medical Oncology, Principal Investigator, Clinical Professor, Yuhong Li
Sun Yat-sen University