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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Oral Mucositis

In brief

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.

Key facts

Study ID

NCT00901732

Run by

Jazz Pharmaceuticals

People needed

100

Starts

2009-05-01

Expected to finish

2010-11-01

Last updated by the study team

2009-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Florida College of Medicine — Gainesville, Florida, United States (enrolling)
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Beth Israel Medical Center — New York, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Temple University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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