Clinical trial NCT02909478: Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer
Official title: Steroid-free Regimen With Aprepitant in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer Receiving FOLFOX Chemotherapy: a Randomized Phase 3 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy-induced Nausea and Vomiting
Colorectal Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of colorectal cancer
* No prior chemotherapy and scheduled to receive FOLFOX chemotherapy (oxaliplatin,leucovorin and 5-fluorouracil)
* Age ≥18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
* Laboratory index: Hemoglobin ≥ 90 g/L (No blood transfusion within 14 days), Absolute Neutrophil Count ≥ 1.5×10\^9/L, Platelet Count ≥ 75×10\^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 3.0×ULN (without liver metastases), ALT and AST ≤ 5.0×ULN (with liver metastases), Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance\>60ml/min
* Be able to read, understand and complete the questionnaire and diary
* Be able to understand the study procedures and sign informed consent.

Exclusion Criteria:

* Treatment with any other study medicine within 4 weeks before enrollment.
* Nausea or vomiting ≤ 24 hours prior to registration
* Ongoing emesis due to obstruction of digestive tract
* Concurrent use of olanzapine, phenothiazine or amifostine
* Female with pregnancy or lactation
* Severe cognitive compromise
* Known history of CNS disease (e.g. brain metastases, seizure disorder)
* Concurrent abdominal radiotherapy
* Chronic alcoholism
* Known hypersensitivity to aprepitant, tropisetron, or dexamethasone.
* Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months.
* History of uncontrolled diabetes mellitus
* Serious or uncontroled infection
* Known active HIV, viral hepatitis or tuberculosis infections

Primary outcomes:
measure: Complete response
timeFrame: Day 1 to Day 5 after chemotherapy
Secondary outcomes:
measure: Nausea score
timeFrame: Day 1 to Day 5 after chemotherapy
measure: Time to First Vomiting Episode or Use of Rescue Medication
timeFrame: Day 1 to Day 5 after chemotherapy
measure: Frequency of rescue medication
timeFrame: Day 1 to Day 5 after chemotherapy
measure: Complete response in the acute phase (0-24 hours)
timeFrame: 0 to 24 hours after chemotherapy
measure: Complete response in the delay phase (25 hours-120 hours)
timeFrame: Day 2 to Day 5 (25 hours-120 hours) after chemotherapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Gastrointestinal Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yanhong Deng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng Y, Wu Z, Shi L, Shen C, Zhang J, Hu H, Li W, Cai Y, Xie X, Ling J, Zheng Q, Deng Y. Aprepitant plus palonosetron versus dexamethasone plus palonosetron in preventing chemotherapy-induced nausea and vomiting in patients with moderate-emetogenic chemotherapy: A randomized, open-label, phase 3 trial. EClinicalMedicine. 2022 Jun 3;49:101480. doi: 10.1016/j.eclinm.2022.101480. eCollection 2022 Jul.