Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

Sponsor

University of Vermont (Other)

Overall Status

Completed

CT.gov ID

NCT01252498

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer of the Head and Neck Radiotherapy

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.

Study Design

Study Type:

Observational

Actual Enrollment :

9 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

A Pilot Study to Evaluate the Role of Cyclooxygenase Pathway in Radiation Therapy and Chemoradiation Therapy Induced Mucositis in Head and Neck Cancer Patients

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Radiotherapy Patients receiving radiotherapy or chemoradiotherapy for head and neck cancer

Outcome Measures

Primary Outcome Measures

Salivary levels of PGE2 and PGI2 during and after radiotherapy [10 weeks after initiation of therapy]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fletcher Allen Health Care	Burlington	Vermont	United States	05401

Sponsors and Collaborators

University of Vermont

Investigators

Principal Investigator: Claire Verschraegen, MD, University of Vermont/Fletcher Allen Health Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Claire Verschraegen, Professor of Medicine, University of Vermont

ClinicalTrials.gov Identifier:

NCT01252498

Other Study ID Numbers:

VCC1005

First Posted:

Dec 3, 2010

Last Update Posted:

Feb 4, 2014

Last Verified:

Feb 1, 2014

Keywords provided by Claire Verschraegen, Professor of Medicine, University of Vermont

Cancer of the head and neck

Radiotherapy

Prostaglandins

Additional relevant MeSH terms:

Head and Neck Neoplasms

Mucositis

Study Results

No Results Posted as of Feb 4, 2014