Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
Conditions
Oral Mucositis
Conditions: official terms
Head and Neck Neoplasms - Mucositis - Stomatitis
Conditions: Keywords
Caphosol, Oral Mucositis, Eusa Pharma, Moffitt Cancer Center
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Intervention
Name: Caphosol
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
University of Florida College of Medicine
Gainesville, Florida, United States
Status: Recruiting
Contact: Robert Amdur, MD
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Status: Recruiting
Contact: Andy Trotti, MD - 813-745-8424
Beth Israel Medical Center
New York, New York, United States
Status: Recruiting
Contact: Kenneth Hu, MD
Duke University Medical Center
Durham, North Carolina, United States
Status: Recruiting
Contact: David Brizel, MD
Temple University Hospital
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Curtis T Miyamoto, MD
MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Mark Chambers, MD
Start Date
May 2009
Completion Date
November 2010
Sponsors
EUSA Pharma (US), Inc.
Source
EUSA Pharma (US), Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page