Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

Completed

• Conditions: Cancer of the Head and Neck; Radiotherapy

• Registration Number: NCT01252498
• Lead Sponsor: University of Vermont

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Salivary levels of PGE2 and PGI2 during and after radiotherapy	10 weeks after initiation of therapy

Secondary Outcome Measures

Name	Time	Method
Patient reports of oral pain during and after radiation therapy	10 weeks after initiation of radiotherapy
Observed mucositis during and after radiotherapy	10 weeks after initiation of radiotherapy

Trial Locations

Locations (1)

Fletcher Allen Health Care; 🇺🇸 Burlington, Vermont, United States