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

NCT00901732 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-05-14

No results posted yet for this study

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.

Conditions

  • Oral Mucositis

Interventions

DEVICE

Caphosol

Oral Mouth Rinse

Sponsors & Collaborators

Principal Investigators

  • Andy M Trotti, MD · Moffitt Cancer Center, Tampa Florida

  • David M Brizel, MD · Duke University, Durham, North Carolina

  • David I Rosenthal, MD · MD Anderson Cancer Center, Houston, Texas

  • Mark Chambers, MD · MD Anderson Cancer Center, Houston, Texas

  • Curtis T Miyamoto, MD · Temple University Hospital, Philadelphia, PA

  • Kenneth Hu, MD · Beth Israel Medical Center, New York, New York

  • Robert Amdur, MD · University of Florida, Gainesville, Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00901732 on ClinicalTrials.gov