Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

February 3, 2014 updated by: Claire Verschraegen, University of Vermont

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Radiotherapy
Patients receiving radiotherapy or chemoradiotherapy for head and neck cancer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 2, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 3, 2010

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCC1005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe