Clincosm LogoSign in Get a demo

Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation

Sponsor
Thomas Jefferson University (Other)
Overall Status
Completed
CT.gov ID
NCT00716157
Collaborator
Merck Sharp & Dohme LLC (Industry)
40
Enrollment
1
Location
83
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Questionnaire study to observe the incidence and pattern or nausea and vomiting in patients receiving combined chemotherapy and radiation. 83% of patients experience radiation therapy-induced vomiting; significant nausea and vomiting could develop with concurrent chemotherapy despite standard anti-nauseous medication prophylaxis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Questionnaires will be answered daily on a weekly basis during period of radiation and chemotherapy.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Study to Evaluate the Incidence and Patterns of Nausea and Vomiting in Patients Receiving Combined Chemotherapy and Radiation
    Study Start Date :
    Oct 1, 2004
    Actual Primary Completion Date :
    Aug 1, 2008
    Actual Study Completion Date :
    Sep 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Observation

    Adult patients receiving both radiation therapy and chemotherapy

    Outcome Measures

    Primary Outcome Measures

    1. Assess incidence and patterns of nausea and vomiting in patients undergoing concurrent chemotherapy and radiation [week of treatment]

    Secondary Outcome Measures

    1. Assess the impact of nausea and vomiting on the patients' daily functioning [week of treatment]

    2. Study the incidence of mucositis and esophagitis [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:

    • Concurrent radiation and chemotherapy treatment

    • Aerodigestive malignancy

    Exclusion Criteria:
    • Other causes of vomiting (i.e.gastrointestinal obstruction...)

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Thomas Jefferson University
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Rita Axelrod, MD, Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT00716157
    Other Study ID Numbers:
    • 04C.466
    • 2004-16
    • 1002004024
    First Posted:
    Jul 16, 2008
    Last Update Posted:
    Dec 5, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Esophageal Neoplasms
    Lung Neoplasms
    Vomiting

    Study Results

    No Results Posted as of Dec 5, 2014