Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

University of Vermont9 enrolled

Overview

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

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

Conditions

Cancer of the Head and Neck Radiotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Fletcher Allen Health Care

Burlington, Vermont, United States

Outcomes

Primary Outcomes

Salivary levels of PGE2 and PGI2 during and after radiotherapy

Time frame: 10 weeks after initiation of therapy

Secondary Outcomes

Observed mucositis during and after radiotherapy

Time frame: 10 weeks after initiation of radiotherapy

Patient reports of oral pain during and after radiation therapy

Time frame: 10 weeks after initiation of radiotherapy

Data from ClinicalTrials.gov

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