Evaluation of the Role of Prostaglandins in Radiation-ind... | NCT01252498

Studies
Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

NCT01252498

Sponsor

University of Vermont

Status

Completed

Last Update Posted

Feb 4, 2014Estimated

Enrollment

9Actual

Phase

Not provided

Conditions

Cancer of the Head and Neck
Radiotherapy

Interventions

Not provided

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

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Dec 2, 2010

First Submission Date that Met QC Criteria

Dec 2, 2010

First Posted Date

Dec 3, 2010Estimated

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

Feb 3, 2014

Last Update Posted Date

Feb 4, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study will evaluate the role of cyclooxygenase pathways in radiation-induced and chemoradiation-induced mucositis.

Detailed Description

Oral mucositis is a significant toxicity of radiation therapy and chemoradiation therapy in head and neck cancer patients. However the mechanisms that induce such mucositis are not completely understood. Previous work evaluating mucositis in bone marrow transplant patients has suggested that prostaglandin levels may be associated with the appearance of mucositis.

The present study will measure the levels in saliva of the prostaglandins PGE2 and PGI2 before, during, immediately after, and several weeks after radiotherapy for head and neck cancer. These salivary levels will be correlated with clinical observation of mucositis and patient reporting of pain levels.

Improved understanding of the mechanism of mucositis may lead to the development of more effective targeted agents to prevent this problem.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiotherapy		Patients receiving radiotherapy or chemoradiotherapy for head and neck cancer

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Salivary levels of PGE2 and PGI2 during and after radiotherapy		10 weeks after initiation of therapy

Secondary Outcomes

Measure	Description	Time Frame
Observed mucositis during and after radiotherapy		10 weeks after initiation of radiotherapy
Patient reports of oral pain during and after radiation therapy		10 weeks after initiation of radiotherapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
Receiving radiation therapy or chemoradiation therapy to the oropharynx
Older than 18 years old
ECOG performance status of 0-2
Life expectancy greater than 2 months
Signed informed consent

Exclusion Criteria:

Previous chemotherapy for this malignancy
Previous radiotherapy to the head and neck
Other cancer diagnosis within the last 5 years except for non-melanoma skin cancer or non-metastatic prostate cancer
Patient taking NSAIDs

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

Patients receiving radiotherapy or chemoradiotherapy for oral cancers. Consecutive patients will be invited to participate.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claire Verschraegen, MD	University of Vermont/Fletcher Allen Health Care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fletcher Allen Health Care		Burlington	Vermont	05401	United States

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided