Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saliva Sample
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
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.
Sites / Locations
- University of Michigan Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Healthy Adults
Radiation for Head and Neck Cancer
Arm Description
Healthy adults over the age of 18, with no history of surgery to the salivary glands, or cancer therapy.
History of radiation therapy for head and neck cancer.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01663246
First Posted
July 24, 2012
Last Updated
August 14, 2014
Sponsor
University of Michigan Rogel Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01663246
Brief Title
Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer
Official Title
Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan Rogel Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Adults
Arm Type
Active Comparator
Arm Description
Healthy adults over the age of 18, with no history of surgery to the salivary glands, or cancer therapy.
Arm Title
Radiation for Head and Neck Cancer
Arm Type
Active Comparator
Arm Description
History of radiation therapy for head and neck cancer.
Intervention Type
Procedure
Intervention Name(s)
Saliva Sample
Intervention Description
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.
Primary Outcome Measure Information:
Title
prevalence of dental caries in patients after PS-IMRT
Description
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
Time Frame
24 Months
Title
prevalence of tooth loss in patients after PS-IMRT
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
prevalence of periodontal disease after PS-IMRT
Description
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.
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avraham Eisbruch, MD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer
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