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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663246
• Other study ID #: 2005.097
• Secondary ID: HUM00000970
• Status: Completed
• Phase: N/A
• First received: July 24, 2012
• Last updated: August 14, 2014
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: August 2014
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• Saliva Sample
Small plastic cups will be placed on the inside of subject cheeks, and held in place with gentle suction. These cups are attached to tubes which will allow the collection of saliva into a test tube. Saliva will also be collected from the glands underneath the tongue using a small gentle suction device, similar to the one used by a dentist. Saliva production will be stimulated by dabbing a mild citric acid solution that tastes like lemon onto the tongue using a Q-Tip. After this test, subjects will also be asked to chew wax to simulate saliva, and the saliva that accumulates in their mouth will be collected by spitting into a test tube.

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of dental caries in patients after PS-IMRT	Various surveys and questionnaires administered for data collection as well as potential risk indicators for dental caries. Oral examination and saliva specimins collected will determine acid, plaque and exposure to tobacco products	24 Months	No
Primary	prevalence of tooth loss in patients after PS-IMRT	Various surveys and questionnaires administered for data collection as well as potential risk indicators for dental caries. Oral examination and saliva specimins collected will determine acid, plaque and exposure to tobacco products	24 months	No
Secondary	prevalence of periodontal disease after PS-IMRT	number of caries in individual subjects will depend on number of teeth and/or surfaces at risk, we will need to report "prevalence" after adjusting for the total surfaces at risk for each patient. In addition, because data in the cross-sectional cohort will be obtained from patients at different follow-up times since RT, the relationship between prevalence and time since RT will need to be explored to take into account the time effect.	24 Months	No