Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting
NCT ID: NCT02484911
Last Updated: 2017-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2015-05-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Olanzapine regimen
Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
Olanzapine
5mg,twice a day orally on day 1 to day 4
Aprepitant
125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
Palonosetron
0.25mg IV 30-60min before chemotherapy on day 1
Dexamethasone
6mg IV on day 1 ，3.75mg IV on day 2 to 4
Control regimen
Aprepitant in combination with palonosetron and dexamethasone
Aprepitant
125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
Palonosetron
0.25mg IV 30-60min before chemotherapy on day 1
Dexamethasone
6mg IV on day 1 ，3.75mg IV on day 2 to 4
Interventions
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Olanzapine
5mg,twice a day orally on day 1 to day 4
Aprepitant
125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
Palonosetron
0.25mg IV 30-60min before chemotherapy on day 1
Dexamethasone
6mg IV on day 1 ，3.75mg IV on day 2 to 4
Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed malignant disease
3. Accept chemotherapy for the first time
4. Patients who will receive high emetogenic cancer chemotherapy (HEC) (cisplatin\>=70mg/m2,adriamycin in combination with cyclophosphamide ,cyclophosphamide\>=1500mg/m2,adriamycin\>60mg/m2,epirubicin\>90mg/m2,dacarbazine，ifosfamide\>=2g/m2) or moderate emetogenic chemotherapy cancer (carboplatin\>=300mg/m2,cyclophosphamide\>=600-1000mg/m2,adriamycin\>50mg/m2)
5. Written informed consent
Exclusion Criteria
2. Uncontrolled psychosis history
3. Inability or unwillingness to understand or cooperate with study procedures
4. Central nervous system tumors primary or secondary
5. Concurrent abdominal radiotherapy
6. History of uncontrolled diabetes mellitus
7. Patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma.
8. Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month
9. Pre-existing nausea or vomiting
10. Inadequate hematological function and abnormal liver and renal function.
11. History of sensitivity to olanzapine
12. Concurrent application of quinolone antibiotic therapy
13. Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy.
14. Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
15. Concurrent application of systemic corticosteroids
16. Active infection or gastrointestinal dysfunction
18 Years
ALL
No
Sponsors
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Harbin Medical University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Responsible Party
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Principal Investigators
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Daxin Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Harbin Medical University
Locations
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First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Countries
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References
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Andrews PL, Naylor RJ, Joss RA. Neuropharmacology of emesis and its relevance to anti-emetic therapy. Consensus and controversies. Support Care Cancer. 1998 May;6(3):197-203. doi: 10.1007/s005200050154.
Matsuki N, Torii Y, Saito H. Effects of iron and deferoxamine on cisplatin-induced emesis: further evidence for the role of free radicals. Eur J Pharmacol. 1993 Dec 1;248(4):329-31. doi: 10.1016/0926-6917(93)90008-e.
Tattersall FD, Rycroft W, Cumberbatch M, Mason G, Tye S, Williamson DJ, Hale JJ, Mills SG, Finke PE, MacCoss M, Sadowski S, Ber E, Cascieri M, Hill RG, MacIntyre DE, Hargreaves RJ. The novel NK1 receptor antagonist MK-0869 (L-754,030) and its water soluble phosphoryl prodrug, L-758,298, inhibit acute and delayed cisplatin-induced emesis in ferrets. Neuropharmacology. 2000 Feb 14;39(4):652-63. doi: 10.1016/s0028-3908(99)00172-0.
Hesketh PJ, Van Belle S, Aapro M, Tattersall FD, Naylor RJ, Hargreaves R, Carides AD, Evans JK, Horgan KJ. Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists. Eur J Cancer. 2003 May;39(8):1074-80. doi: 10.1016/s0959-8049(02)00674-3.
Grunberg SM, Hesketh PJ. Control of chemotherapy-induced emesis. N Engl J Med. 1993 Dec 9;329(24):1790-6. doi: 10.1056/NEJM199312093292408.
Grunberg SM, Slusher B, Rugo HS. Emerging treatments in chemotherapy-induced nausea and vomiting. Clin Adv Hematol Oncol. 2013 Feb;11(2 Suppl 1):1-18; quiz 2 p following 18.
Diemunsch P, Grelot L. Potential of substance P antagonists as antiemetics. Drugs. 2000 Sep;60(3):533-46. doi: 10.2165/00003495-200060030-00002.
Gao HF, Liang Y, Zhou NN, Zhang DS, Wu HY. Aprepitant plus palonosetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy. Intern Med J. 2013 Jan;43(1):73-6. doi: 10.1111/j.1445-5994.2011.02637.x.
Tan L, Liu J, Liu X, Chen J, Yan Z, Yang H, Zhang D. Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res. 2009 Sep 23;28(1):131. doi: 10.1186/1756-9966-28-131.
Navari RM, Gray SE, Kerr AC. Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol. 2011 Sep-Oct;9(5):188-95. doi: 10.1016/j.suponc.2011.05.002. Epub 2011 Sep 24.
Related Links
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Other Identifiers
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GHYDZ-1225
Identifier Type: -
Identifier Source: org_study_id
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