Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
1 other identifier
interventional
100
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2009
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 13, 2009
CompletedFirst Posted
Study publicly available on registry
May 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedMay 14, 2009
May 1, 2009
1.5 years
May 13, 2009
May 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake)
15 weeks
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Florida College of Medicine
Gainesville, Florida, 32610, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andy M Trotti, MD
Moffitt Cancer Center, Tampa Florida
- STUDY DIRECTOR
David M Brizel, MD
Duke University, Durham, North Carolina
- PRINCIPAL INVESTIGATOR
David I Rosenthal, MD
MD Anderson Cancer Center, Houston, Texas
- STUDY DIRECTOR
Mark Chambers, MD
MD Anderson Cancer Center, Houston, Texas
- STUDY DIRECTOR
Curtis T Miyamoto, MD
Temple University Hospital, Philadelphia, PA
- STUDY DIRECTOR
Kenneth Hu, MD
Beth Israel Medical Center, New York, New York
- STUDY DIRECTOR
Robert Amdur, MD
University of Florida, Gainesville, Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 13, 2009
First Posted
May 14, 2009
Study Start
May 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
May 14, 2009
Record last verified: 2009-05