Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis
Cancer of the Head and Neck
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|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|
- Salivary levels of PGE2 and PGI2 during and after radiotherapy [ Time Frame: 10 weeks after initiation of therapy ] [ Designated as safety issue: No ]
- Observed mucositis during and after radiotherapy [ Time Frame: 10 weeks after initiation of radiotherapy ] [ Designated as safety issue: No ]
- Patient reports of oral pain during and after radiation therapy [ Time Frame: 10 weeks after initiation of radiotherapy ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
|Study Start Date:||December 2010|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Patients receiving radiotherapy or chemoradiotherapy for head and neck cancer
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252498
|United States, Vermont|
|Fletcher Allen Health Care|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Claire Verschraegen, MD||University of Vermont/Fletcher Allen Health Care|