Status:
UNKNOWN
Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Oral Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00901732
Start Date
May 1 2009
End Date
November 1 2010
Last Update
May 14 2009
Active Locations (6)
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1
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
2
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Beth Israel Medical Center
New York, New York, United States, 10003
4
Duke University Medical Center
Durham, North Carolina, United States, 27710