Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation

NCT00001523 | Completed

• 2 other identifiers: 96008296-D-0082
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Radiation Injuries; Xerostomia

Keywords

Cytology; Diagnostic Imaging; Radiation Damage; Saliva; Serostomia; Xerostomia; Head Cancer; Neck Cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Radiation Injuries; Xerostomia; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Wounds and Injuries; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: May 1, 1996
• Study Completion: March 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-06

Locations

US (1)