Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation
March 3, 2008 updated by: National Institute of Dental and Craniofacial Research (NIDCR)
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
-
Bethesda, Maryland, United States, 20892
- National Institute of Dental and Craniofacial Research (NIDCR)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 1996
Study Completion
March 1, 2000
Study Registration Dates
First Submitted
November 3, 1999
First Submitted That Met QC Criteria
December 9, 2002
First Posted (Estimate)
December 10, 2002
Study Record Updates
Last Update Posted (Estimate)
March 4, 2008
Last Update Submitted That Met QC Criteria
March 3, 2008
Last Verified
June 1, 1999
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 960082
- 96-D-0082
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.