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Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation Clinical research trials and Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation. Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation clinical trial. Subjects typically recieve the finest healthcare available for their Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation  Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation
Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation
For Condition: Radiation Injuries,Xerostomia
Status: Completed
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 20
Location and Contact Information:
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 960082; 96-D-0082
Study Start Date: May 31, 1996
Record last reviewed: June 10, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001523
Other Xerostomia Studies:
1. Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation
2. Evaluation of Salivary Gland Dysfunction
3. DHEA Treatment for Sjogren's Syndrome
4. Natural History of Salivary Gland Dysfunction and Sjogren's Syndrome
5. Pilot Study of Thalidomide to Treat Sjogren's Syndrome
Related Studies:
Other Xerostomia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation
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