Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
Phase 1
- Conditions
- Oral Mucositis
- Registration Number
- NCT00901732
- Lead Sponsor
- Jazz Pharmaceuticals
- 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 had any effect on clinical outcomes which include quality of life, oral intake, swallowing function and pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The primary objective is to estimate ht incidence of OM in H&N cancer patients undergoing radiation therapy with or without chemotherapy and/or sensitizer who receive Caphosol. 15 weeks
- Secondary Outcome Measures
Name Time Method The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake) 15 weeks
Trial Locations
- Locations (6)
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States