Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
NCT ID: NCT00901732
Last Updated: 2009-05-14
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
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UNKNOWN
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2009-05-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Interventions
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Caphosol
Oral Mouth Rinse
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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EUSA Pharma (USA), INc
Principal Investigators
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Andy M Trotti, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center, Tampa Florida
David M Brizel, MD
Role: STUDY_DIRECTOR
Duke University, Durham, North Carolina
David I Rosenthal, MD
Role: PRINCIPAL_INVESTIGATOR
MD Anderson Cancer Center, Houston, Texas
Mark Chambers, MD
Role: STUDY_DIRECTOR
MD Anderson Cancer Center, Houston, Texas
Curtis T Miyamoto, MD
Role: STUDY_DIRECTOR
Temple University Hospital, Philadelphia, PA
Kenneth Hu, MD
Role: STUDY_DIRECTOR
Beth Israel Medical Center, New York, New York
Robert Amdur, MD
Role: STUDY_DIRECTOR
University of Florida, Gainesville, Florida
Locations
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University of Florida College of Medicine
Gainesville, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Beth Israel Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Robert Amdur, MD
Role: primary
Bridgett Fitzgerald
Role: backup
Andy Trotti, MD
Role: primary
Kenneth Hu, MD
Role: primary
David Brizel, MD
Role: primary
Curtis T Miyamoto, MD
Role: primary
Jennifer Curry, RN
Role: backup
Mark Chambers, MD
Role: primary
Other Identifiers
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603EUSA03
Identifier Type: -
Identifier Source: org_study_id
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