Last updated: July 24, 2021
Sponsor: Sun Yat-sen University
Overall Status: Completed
Phase
3
Condition
Vomiting
Lactose Intolerance
Colon Cancer; Rectal Cancer
Treatment
N/AClinical Study ID
NCT02909478
GIHSYSU12
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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), AbsoluteNeutrophil 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 livermetastases), 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
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 myocardialinfarction within the previous six months.
- History of uncontrolled diabetes mellitus
- Serious or uncontroled infection
- Known active HIV, viral hepatitis or tuberculosis infections
Study Design
Total Participants: 315
Study Start date:
September 01, 2017
Estimated Completion Date:
December 31, 2019
Connect with a study center
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510655
ChinaSite Not Available

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