A Pilot Study to Evaluate the Role of Cyclooxygenase Pathway in Radiation Therapy and Chemoradiation Therapy Induced Mucositis in Head and Neck Cancer Patients
18 Years
N/A
Both
Cancer of the Head and Neck, Radiotherapy
Trial Information
A Pilot Study to Evaluate the Role of Cyclooxygenase Pathway in Radiation Therapy and Chemoradiation Therapy Induced Mucositis in Head and Neck Cancer Patients
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Salivary levels of PGE2 and PGI2 during and after radiotherapy
Outcome Time Frame:
10 weeks after initiation of therapy
Safety Issue:
No
Principal Investigator
Steven M Grunberg, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Vermont/Fletcher Allen Health Care
Authority:
United States: Institutional Review Board
Study ID:
VCC1005
NCT ID:
NCT01252498
Start Date:
December 2010
Completion Date:
December 2012
Related Keywords:
- Cancer of the Head and Neck
- Radiotherapy
- Cancer of the head and neck
- Radiotherapy
- Prostaglandins
- Head and Neck Neoplasms
- Mucositis
Name | Location |
|---|---|
| Fletcher Allen Health Care | Burlington, Vermont 05401 |
