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

Primary Purpose

Oral Mucositis

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Caphosol
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Oral Mucositis focused on measuring Caphosol, Oral Mucositis, Eusa Pharma, Moffitt Cancer Center

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida College of MedicineRecruiting
  • H. Lee Moffitt Cancer CenterRecruiting
  • Beth Israel Medical CenterRecruiting
  • Duke University Medical CenterRecruiting
  • Temple University HospitalRecruiting
  • MD Anderson Cancer CenterRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake)

Full Information

First Posted
May 13, 2009
Last Updated
May 13, 2009
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00901732
Brief Title
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

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Caphosol, Oral Mucositis, Eusa Pharma, Moffitt Cancer Center

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Caphosol
Other Intervention Name(s)
supersaturated solution of calcium and phosphate ions.
Intervention Description
Oral Mouth Rinse
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Manyak, MD
Phone
609-750-8200
Email
michael.manyak@eusapharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Gramkowski, MST
Phone
609-750-8219
Email
colleen.gramkowski@eusapharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy M Trotti, MD
Organizational Affiliation
Moffitt Cancer Center, Tampa Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David M Brizel, MD
Organizational Affiliation
Duke University, Durham, North Carolina
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David I Rosenthal, MD
Organizational Affiliation
MD Anderson Cancer Center, Houston, Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Chambers, MD
Organizational Affiliation
MD Anderson Cancer Center, Houston, Texas
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Curtis T Miyamoto, MD
Organizational Affiliation
Temple University Hospital, Philadelphia, PA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kenneth Hu, MD
Organizational Affiliation
Beth Israel Medical Center, New York, New York
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert Amdur, MD
Organizational Affiliation
University of Florida, Gainesville, Florida
Official's Role
Study Director
Facility Information:
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Amdur, MD
First Name & Middle Initial & Last Name & Degree
Bridgett Fitzgerald
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andy Trotti, MD
Phone
813-745-8424
First Name & Middle Initial & Last Name & Degree
Margaret Lotrimare
Phone
813-745-7223
Email
margaret.lomartire@moffitt.org
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Hu, MD
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Brizel, MD
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Curtis T Miyamoto, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Curry, RN
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Chambers, MD

12. IPD Sharing Statement

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

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