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

NCT ID: NCT00901732

Last Updated: 2009-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Mucositis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Caphosol

Oral Mouth Rinse

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

supersaturated solution of calcium and phosphate ions.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

EUSA Pharma (USA), INc

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andy M Trotti, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center, Tampa Florida

David M Brizel, MD

Role: STUDY_DIRECTOR

Duke University, Durham, North Carolina

David I Rosenthal, MD

Role: PRINCIPAL_INVESTIGATOR

MD Anderson Cancer Center, Houston, Texas

Mark Chambers, MD

Role: STUDY_DIRECTOR

MD Anderson Cancer Center, Houston, Texas

Curtis T Miyamoto, MD

Role: STUDY_DIRECTOR

Temple University Hospital, Philadelphia, PA

Kenneth Hu, MD

Role: STUDY_DIRECTOR

Beth Israel Medical Center, New York, New York

Robert Amdur, MD

Role: STUDY_DIRECTOR

University of Florida, Gainesville, Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Florida College of Medicine

Gainesville, Florida, United States

Site Status RECRUITING

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Beth Israel Medical Center

New York, New York, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Michael Manyak, MD

Role: CONTACT

609-750-8200

Colleen Gramkowski, MST

Role: CONTACT

609-750-8219

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Robert Amdur, MD

Role: primary

Bridgett Fitzgerald

Role: backup

Andy Trotti, MD

Role: primary

813-745-8424

Margaret Lotrimare

Role: backup

813-745-7223

Kenneth Hu, MD

Role: primary

David Brizel, MD

Role: primary

Curtis T Miyamoto, MD

Role: primary

Jennifer Curry, RN

Role: backup

Mark Chambers, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

603EUSA03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients
NCT04651634 ACTIVE_NOT_RECRUITING PHASE2
Omega-3 Hydrogel and Prevention of Oral Mucositis
NCT05214495 COMPLETED PHASE2/PHASE3