Structure & Functional Status of Parotid Glands Exposed to NCT00001523

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00001523
Other study ID #	960082
Secondary ID	96-D-0082
Status	Completed
Phase	N/A
First received	November 3, 1999
Last updated	March 3, 2008
Start date	May 1996
Est. completion date	March 2000

Study information
Verified date	June 1999
Source	National Institutes of Health Clinical Center (CC)
Contact	n/a
Is FDA regulated	No
Health authority	United States: Federal Government
Study type	Observational

Clinical Trial 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.

Description:

Recruitment information / eligibility
Status	Completed
Enrollment	20
Est. completion date	March 2000
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	N/A and older
Eligibility	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 Design

N/A

Related Conditions & MeSH terms

Locations
Country	Name	City	State
United States	National Institute of Dental And Craniofacial Research (NIDCR)	Bethesda	Maryland

Sponsors *(1)*
Lead Sponsor	Collaborator
National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States,

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Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Locations

Sponsors (1)

Country where clinical trial is conducted