Clinical trial NCT00901732: Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
Official title: Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Oral Mucositis
Keywords: Caphosol
Oral Mucositis
Eusa Pharma
Moffitt Cancer Center
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-05-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 15 weeks
Secondary outcomes:
measure: The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake)
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Moffitt Cancer Center, Tampa Florida
name: Andy M Trotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University, Durham, North Carolina
name: David M Brizel, MD
role: STUDY_DIRECTOR
affiliation: MD Anderson Cancer Center, Houston, Texas
name: David I Rosenthal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MD Anderson Cancer Center, Houston, Texas
name: Mark Chambers, MD
role: STUDY_DIRECTOR
affiliation: Temple University Hospital, Philadelphia, PA
name: Curtis T Miyamoto, MD
role: STUDY_DIRECTOR
affiliation: Beth Israel Medical Center, New York, New York
name: Kenneth Hu, MD
role: STUDY_DIRECTOR
affiliation: University of Florida, Gainesville, Florida
name: Robert Amdur, MD
role: STUDY_DIRECTOR
References: