View Clinical Trial (Medical Research Study)
A Pilot Study to Evaluate the Role of Cyclooxygenase Pathway in Radiation Therapy and Chemoradiation Therapy Induced Mucositis in Head and Neck Cancer Patients
| City: |
|
Burlington |
| State: |
|
Vermont |
| Zip Code: |
|
05401 |
| Conditions: |
|
Cancer of the Head and Neck - Radiotherapy |
| Purpose: |
|
This study will evaluate the role of cyclooxygenase pathways in radiation-induced and
chemoradiation-induced mucositis.
|
| Study Summary: |
|
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.
|
| Criteria: |
|
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
|
| NCT ID: |
|
NCT01252498 |
| Primary Contact: |
|
Principal Investigator
Steven M Grunberg, MD
University of Vermont/Fletcher Allen Health Care
Steven M Grunberg, MD
Phone: 802-847-8400
Email: Steven.Grunberg@uvm.edu
|
| Backup Contact: |
|
Email: Nathan.Adams@vtmednet.org
Nathan B Adams, MD
Phone: 802-847-8400
|
| Location Contact: |
|
Burlington, Vermont 05401
United States
Steven M Grunberg, MD
Phone: 802-847-8400
Email: Steven.Grunberg@uvm.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 17, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|