Clinical trial NCT03674294: Aprepitant Triple Therapy for the Prevention of CINV in Nondrinking and Young Women Who Received Moderately Emetogenic Chemotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Neoplasms
Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 248
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete response rate during the overall phase
timeFrame: Up to 1-2 months
Secondary outcomes:
measure: Complete response rate in the acute phase
timeFrame: Up to 1-2 months
measure: Complete response rate in the delayed phase
timeFrame: Up to 1-2 months
measure: No vomiting rate in the acute phase, delayed phase and overall phase
timeFrame: Up to 1-2 months
measure: Affection caused by CINV reported by patients
timeFrame: Up to 1-2 months
measure: Effects of CINV on daily life
timeFrame: Up to 1-2 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
citation: Wang DS, Hu MT, Wang ZQ, Ren C, Qiu MZ, Luo HY, Jin Y, Fong WP, Wang SB, Peng JW, Zou QF, Tan Q, Wang FH, Li YH. Effect of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Women: A Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e215250. doi: 10.1001/jamanetworkopen.2021.5250.