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Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin

Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
Overall Status
Terminated
CT.gov ID
NCT00716560
Collaborator
Merck Sharp & Dohme LLC (Industry)
8
Enrollment
1
Location
46
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to observe the incidence of nausea with systemic chemotherapy that includes consecutive days (more than one day)of cisplatin medication.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Questionnaires are completed on week of chemotherapy treatment referred to as Dartmouth regimen.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    8 participants
    Observational Model:
    Case-Only
    Official Title:
    Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin
    Study Start Date :
    May 1, 2005
    Actual Primary Completion Date :
    Mar 1, 2009
    Actual Study Completion Date :
    Mar 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    A

    Metastatic melanoma treatment with Dartmouth regimen

    Outcome Measures

    Primary Outcome Measures

    1. Determine incidence of nausea when receiving Dartmouth regimen chemotherapy for metastatic melanoma [Week of treatment]

    Secondary Outcome Measures

    1. Assess the impact of systemic chemotherapy with Dartmouth regimen on quality of life of patients [week of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • confirmed diagnosis metastatic melanoma

    • 18 years and older

    • undergoing chemotherapy with Dartmouth regimen

    • medically stable to receive chemotherapy per physical and clinical laboratory tests

    Exclusion Criteria:

    • No medical conditions that interfere with assessment of nausea and vomiting during chemotherapy

    • No cognitive disorder that impairs symptom assessment

    • No other investigational agent

    • Inability to swallow medications for nausea and vomiting

    • No gastric outlet obstruction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Sidney Kimmel Cancer Center at Thomas Jefferson University
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Takami Sato, M.D.,Ph.D., Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT00716560
    Other Study ID Numbers:
    • 05C.202
    • 2004-101
    • 0402005015
    First Posted:
    Jul 16, 2008
    Last Update Posted:
    Oct 21, 2016
    Last Verified:
    Oct 1, 2016
    Additional relevant MeSH terms:
    Nausea
    Vomiting

    Study Results

    No Results Posted as of Oct 21, 2016