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

May 13, 2009 updated by: Jazz Pharmaceuticals
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida College of Medicine
        • Contact:
          • Robert Amdur, MD
        • Contact:
          • Bridgett Fitzgerald
      • Tampa, Florida, United States, 33612
        • Recruiting
        • H. Lee Moffitt Cancer Center
        • Contact:
          • Andy Trotti, MD
          • Phone Number: 813-745-8424
        • Contact:
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • Beth Israel Medical Center
        • Contact:
          • Kenneth Hu, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • David Brizel, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital
        • Contact:
          • Curtis T Miyamoto, MD
        • Contact:
          • Jennifer Curry, RN
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
          • Mark Chambers, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 15 weeks
15 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake)
Time Frame: 15 weeks
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 13, 2009

First Posted (Estimate)

May 14, 2009

Study Record Updates

Last Update Posted (Estimate)

May 14, 2009

Last Update Submitted That Met QC Criteria

May 13, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 603EUSA03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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