Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN
NCT ID: NCT02970643
Last Updated: 2016-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
48 participants
INTERVENTIONAL
2016-07-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Olanzapine group
Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group
Olanzapine
Moderate risk chemotherapy induced nausea group in all cancer. D1 Olanzapine 10mg PO D2-3 Olanzapine 10mg PO
Palonosetron
Moderate risk chemotherapy induced nausea group in all cancer. D1 Palonosetron 0.25mg IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Olanzapine
Moderate risk chemotherapy induced nausea group in all cancer. D1 Olanzapine 10mg PO D2-3 Olanzapine 10mg PO
Palonosetron
Moderate risk chemotherapy induced nausea group in all cancer. D1 Palonosetron 0.25mg IV
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* no severe cognitive compromise
* Moderate risk chemotherapy induced chemotherapy induced nausea and vomiting in 1st cycle
* Confirmed histology
Exclusion Criteria
* Nausea or vomiting in the 24 hours before enrollment
* History of Nausea or vomiting Grade 3 before previous chemotherapy
* Known history of central nervous system disease (e.g., brain metastases or a seizure disorder)
* Bowel obstruction
* Serum creatinine level of 2.0 mg per deciliter (177 μmol per liter) or more
* Aspartate or alanine aminotransferase level that was more than 3 times the upper limit of the normal range
* Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment
* Treatment with another antiemetic agent before 48 hours before enrollment
* Uncontrolled severe infection or uncontrolled severe comorbidity
* Concurrent abdominal radiotherapy
* Known hypersensitivity to olanzapine, palonosetron
* Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 month
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HK inno.N Corporation
INDUSTRY
Hee Jun Kim
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hee Jun Kim
Associate Professor,Division of Hemato-oncology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heejun Kim, MD.PhD
Role: STUDY_CHAIR
Associate Professor
References
Explore related publications, articles, or registry entries linked to this study.
Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725.
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.
Naeim A, Dy SM, Lorenz KA, Sanati H, Walling A, Asch SM. Evidence-based recommendations for cancer nausea and vomiting. J Clin Oncol. 2008 Aug 10;26(23):3903-10. doi: 10.1200/JCO.2007.15.9533.
Lohr L. Chemotherapy-induced nausea and vomiting. Cancer J. 2008 Mar-Apr;14(2):85-93. doi: 10.1097/PPO.0b013e31816a0f07.
American Society of Clinical Oncology; Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006 Jun 20;24(18):2932-47. doi: 10.1200/JCO.2006.06.9591. Epub 2006 May 22.
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.
Vardy J, Chiew KS, Galica J, Pond GR, Tannock IF. Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy. Br J Cancer. 2006 Apr 10;94(7):1011-5. doi: 10.1038/sj.bjc.6603048.
Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000 Oct 1;89(7):1634-46. doi: 10.1002/1097-0142(20001001)89:73.0.co;2-v.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C2016034
Identifier Type: -
Identifier Source: org_study_id