Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

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

Detailed Description
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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.

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

Conditions
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Cancer of the Head and Neck, Radiotherapy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiotherapy<br>Patients receiving radiotherapy or chemoradiotherapy for head and neck cancer | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer of the head and neck, Radiotherapy, Prostaglandins