Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001523
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: June 1999
  Purpose

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.


Condition
Radiation Injuries
Xerostomia

Study Type: Observational
Official Title: Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 20
Study Start Date: May 1996
Estimated Study Completion Date: March 2000
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00001523

Locations
United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00001523     History of Changes
Other Study ID Numbers: 960082, 96-D-0082
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cytology
Diagnostic Imaging
Radiation Damage
Saliva
Serostomia
Xerostomia
Head Cancer
Neck Cancer

Additional relevant MeSH terms:
Xerostomia
Radiation Injuries
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014