Completed
Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation
Led by National Institute of Dental and Craniofacial Research (NIDCR) · Updated on 2008-03-04
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Therapeutic irradiation to the head and neck for cancer damages salivary glands present in the radiation field. Despite long recognition of radiation-induced salivary hypofunction, and the associated oral morbidities, the specific damage mechanism(s) is not known and the structure and functional integrity of the surviving parenchymal tissue has not been well-documented. Detailed knowledge of the latter is particularly necessary in order to design appropriate corrective therapies. It is the purpose of this study to provide such a detailed structural and functional assessment of human parotid glands following irradiation. The study will examine 20 patients beginning just prior to therapeutic irradiation and continuing at intervals for 3 years for a total of 5 study visits. Study visits (prior to irradiation and at 4 weeks, 12 weeks, 12 months and 36 months post-irradiation) will include the following procedures: i) detailed oral exam and structured interview; ii) salivary gland functional assessment; iii) sialography of each parotid gland; iv) 99mTcO4 scan of the salivary glands; and v) a magnetic resonance imaging (MRI) scan of the parotid glands. Based on previous single observation studies in humans, and more detailed animal studies, we hypothesize that ionizing radiation will lead to reduced parotid gland function and diminished salivary parenchymal tissue (with a preferential loss in acinar versus ductal cells). Further, we hypothesize that the parenchymal loss will increase with time (replaced by fat and connective tissue) and lead to progressive irreversible salivary dysfunction.
CONDITIONS
Official Title
Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
Age 21-80.
Diagnosis of head and neck cancer.
No surgery OR surgery with parotid glands intact.
Therapeutic radiation greater than or equal to 52 Gy.
Ambulatory.
No OR limited chemotherapy.
No Metastasis.
No allergy to Iodine.
No allergy to shellfish.
No metallic implants in head or neck.
No history of bleeding disorder.
No previous history of dry mouth (xerostomia).
No history of Sjogren's syndrome.
Negative HIV.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892
Status Unknown
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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