Completed

Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation

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What is being collected

Data Collection

Who is being recruted

Stomatognathic Diseases+6

+ Mouth Diseases

+ Neoplasms

See all eligibility criteria
How is the trial designed

Observational
Study Start: May 1996
See protocol details

Summary

Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00001523
Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Stomatognathic DiseasesMouth DiseasesNeoplasmsNeoplasms by SiteSalivary Gland DiseasesWounds and InjuriesHead and Neck NeoplasmsRadiation InjuriesXerostomia

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, United StatesOpen National Institute of Dental And Craniofacial Research (NIDCR) in Google Maps
CompletedOne Study Center