Caphosol for the Reduction of Mucositis in Patients Recei... | NCT00901732

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

NCT00901732

Sponsor

Jazz Pharmaceuticals

Status

Unknown status

Last Update Posted

May 14, 2009Estimated

Enrollment

100Estimated

Phase

Phase 1Phase 2

Conditions

Oral Mucositis

Interventions

Caphosol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Nov 2010Estimated

Completion Date

Nov 2010Estimated

First Submitted Date

May 13, 2009

First Submission Date that Met QC Criteria

May 13, 2009

First Posted Date

May 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2009

Last Update Posted Date

May 14, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caphosol	Device	Oral Mouth Rinse		supersaturated solution of calcium and phosphate ions.

Outcomes Module

Primary Outcomes

Measure	Description	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.		15 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Manyak, MD	Contact	609-750-8200		michael.manyak@eusapharma.com
Colleen Gramkowski, MST	Contact	609-750-8219		colleen.gramkowski@eusapharma.com

Overall Officials

Name	Affiliation	Role
Andy M Trotti, MD	Moffitt Cancer Center, Tampa Florida	Principal Investigator
David M Brizel, MD	Duke University, Durham, North Carolina	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida College of Medicine	Recruiting	Gainesville	Florida	32610	United States

Condition Browse Module

MeSH Terms

ID	Term
D013280	Stomatitis

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided