Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Procedure: Saliva Sample

Study type: Interventional

Funder types: Other

Identifiers

NCT01663246

2005.097

HUM00000970 (Other Identifier)

Details and patient eligibility

About

The investigators are conducting research about oral health and saliva to find out more about the impact of radiation therapy on the oral health of patients.

In order to better understand the role of saliva in maintaining oral health in these patients, the investigators will be collecting, storing, and analyzing the quality of saliva, including the protein content, collected from patients following radiation therapy as well as saliva collected from normal healthy adults.

Full description

Radiation-induced xerostomia is the most common long term complication of head and neck radiation, is usually permanent and is the most frequent reason for reduced quality of life in these patients. The loss of antimicrobial, buffering, cleansing and remineralizing effects of saliva markedly increases the risk for dental caries. Extractions of diseased teeth located in irradiated bone and dental infection involving the bone can trigger osteoradionecrosis (ORN), another serious complication of high dose radiation of the jaws. Therefore, current dental treatment guidelines recommend the extraction of diseased teeth and any teeth that might require extraction in the future, before radiation therapy. (NCI, 1990; Rankin et al, 2003; NIDCR, 2005) As a result, patients with head and neck cancer often have many or all teeth extracted, especially those patients who are judged unlikely to comply with lifelong, daily topical fluoride, oral hygiene practices and frequent professional dental care. (Bruins et al, 1999)

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All subjects who have been enrolled in a parotid-sparing IMRT protocol for head and neck cancer at University of Michigan.
• At least 6 months has elapsed since the completion of RT, at the time of assessment for this study.
• All subjects must sign a University of Michigan Health System- IRB approved informed consent.
• Documented Karnofsky performance status > 60
• These subjects will all have American Joint Committee on Cancer (AJCC) Stage III or Stage IV disease. (Green et al, 2001) (Appendix 2); non-metastatic, curable disease

Exclusion criteria

• History of surgical removal of major salivary gland(s).
• Patients edentulous prior to radiation therapy.
• Pregnancy or lactation
• Patients residing in prison.
• Age< 18 years.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Healthy Adults

Active Comparator group

Description:

Healthy adults over the age of 18, with no history of surgery to the salivary glands, or cancer therapy.

Treatment:

Procedure: Saliva Sample

Radiation for Head and Neck Cancer

Active Comparator group

Description:

History of radiation therapy for head and neck cancer.

Treatment:

Procedure: Saliva Sample