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Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

Information source: University of Vermont
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer of the Head and Neck; Radiotherapy

Phase: N/A

Status: Completed

Sponsored by: University of Vermont

Official(s) and/or principal investigator(s):
Claire Verschraegen, MD, Principal Investigator, Affiliation: University of Vermont/Fletcher Allen Health Care


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

Clinical Details

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 design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Salivary levels of PGE2 and PGI2 during and after radiotherapy

Secondary outcome:

Observed mucositis during and after radiotherapy

Patient reports of oral pain during and after radiation therapy

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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 and Contacts

Fletcher Allen Health Care, Burlington, Vermont 05401, United States
Additional Information

Starting date: December 2010
Last updated: February 3, 2014

Page last updated: August 23, 2015

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