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Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Olanzapine
Palonosetron
Sponsored by
Hee Jun Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting focused on measuring Olanzapine, Chemotherapy-Induced Nausea and Vomiting, Moderate risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • no severe cognitive compromise
  • Moderate risk chemotherapy induced chemotherapy induced nausea and vomiting in 1st cycle
  • Confirmed histology

Exclusion Criteria:

  • European Cooperative Oncology Group (ECOG) performance status of 3 and 4
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Olanzapine group

    Arm Description

    Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group

    Outcomes

    Primary Outcome Measures

    Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 4.0 nausea

    Secondary Outcome Measures

    Quality of life was evaluated according to MDASI-K

    Full Information

    First Posted
    November 16, 2016
    Last Updated
    November 22, 2016
    Sponsor
    Hee Jun Kim
    Collaborators
    HK inno.N Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02970643
    Brief Title
    Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN
    Official Title
    Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    September 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hee Jun Kim
    Collaborators
    HK inno.N Corporation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Palonosetron and Olanzapine without dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.
    Detailed Description
    This study was designed to evaluate efficacy and safety of olanzapine compared with 5-hydroxytryptamine3 receptor antagonist for prevention of moderate risk chemotherapy induced nausea and vomiting.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-induced Nausea and Vomiting
    Keywords
    Olanzapine, Chemotherapy-Induced Nausea and Vomiting, Moderate risk

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Olanzapine group
    Arm Type
    Experimental
    Arm Description
    Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group
    Intervention Type
    Drug
    Intervention Name(s)
    Olanzapine
    Other Intervention Name(s)
    Zyprexa
    Intervention Description
    Moderate risk chemotherapy induced nausea group in all cancer. D1 Olanzapine 10mg PO D2-3 Olanzapine 10mg PO
    Intervention Type
    Drug
    Intervention Name(s)
    Palonosetron
    Other Intervention Name(s)
    Aloxi
    Intervention Description
    Moderate risk chemotherapy induced nausea group in all cancer. D1 Palonosetron 0.25mg IV
    Primary Outcome Measure Information:
    Title
    Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 4.0 nausea
    Time Frame
    the overall assessment period (0 to 72 hours)
    Secondary Outcome Measure Information:
    Title
    Quality of life was evaluated according to MDASI-K
    Time Frame
    the overall assessment period (0 to 72 hours)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 no severe cognitive compromise Moderate risk chemotherapy induced chemotherapy induced nausea and vomiting in 1st cycle Confirmed histology Exclusion Criteria: European Cooperative Oncology Group (ECOG) performance status of 3 and 4 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heejun Kim, MD.PhD
    Organizational Affiliation
    Associate Professor
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27410922
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19775450
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18688059
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18391612
    Citation
    Lohr L. Chemotherapy-induced nausea and vomiting. Cancer J. 2008 Mar-Apr;14(2):85-93. doi: 10.1097/PPO.0b013e31816a0f07.
    Results Reference
    background
    PubMed Identifier
    16717289
    Citation
    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. Erratum In: J Clin Oncol. 2006 Nov 20;24(33):5341-2.
    Results Reference
    background
    PubMed Identifier
    22024310
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16552437
    Citation
    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.
    Results Reference
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    PubMed Identifier
    11013380
    Citation
    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.
    Results Reference
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    Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN

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