Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

Last updated: May 13, 2009
Sponsor: Jazz Pharmaceuticals
Overall Status: Trial Status Unknown

Phase

1/2

Condition

Canker Sores

Mucositis

Treatment

N/A

Clinical Study ID

NCT00901732
603EUSA03
  • Ages > 18
  • All Genders

Study Summary

Patients who have been diagnosed with a head and/or neck cancer commonly develop oral mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral intake, swallowing function and pain.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed Head and Neck Cancer patients with planned Radiation therapy

  • Have at least one of 10 pre-defined anatomic mucosal subsites on view

  • Age >/= 18 years

  • Life expectancy >/= 6 months

  • Planned RT to the head/neck

  • Must be able to perform oral rinse

Exclusion

Exclusion Criteria:

  • Active infections of oral cavity

  • physiologic condition that precludes the use of an oral rinse

  • Hypersensitivity to Caphosol ingredients

  • Presence of mucosal ulceration at baseline

  • Poorly controlled hypertension, DM or other serious medical/psychiatric illness

Study Design

Total Participants: 100
Study Start date:
May 01, 2009
Estimated Completion Date:
November 30, 2010

Connect with a study center

  • University of Florida College of Medicine

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • H. Lee Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Beth Israel Medical Center

    New York, New York 10003
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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