Observational Study of Dental Outcomes in Head and Neck Cancer Patients
Conditions
Head and Neck Cancer - Dental Disease - Xerostomia - Osteoradionecrosis
Conditions: official terms
Head and Neck Neoplasms - Osteoradionecrosis - Tooth Diseases - Xerostomia
Conditions: Keywords
Head and Neck Cancer, Radiation Therapy
Study Type
Observational [Patient Registry]
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
The purpose of this study is to measure the two-year rate of tooth loss in patients who have received external beam radiation therapy with curative intent for head and neck cancer. The study will also evaluate the sequelae of radiation therapy and oral complications that may occur as a result to receiving radiation therapy.
Detailed Description
This is a prospective cohort study to document dental and other oral outcomes in patients who receive external beam radiation therapy with curative intent, as part of clinical care for a head and neck cancer. Seven hundred and fifty-six participants will be enrolled. All study participants will receive a baseline oral examination prior to the start of radiation therapy. Follow-up examinations and data collection will be conducted at six-month intervals up to 2 years after the start of radiation therapy. The primary outcome will be the two-year rate of tooth loss. Secondary outcomes will include measures of dental caries, periodontal health, salivary flow, and exposed bone/osteoradionecrosis.

The proposed research will provide more information to inform the community about the sequelae of Radiation Therapy (RT) in head and neck cancer patients, to refine current guidelines and to design future studies on the dental management of these patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Aged 18 years and older;

- Willing and able to provide signed and dated consent form;

- Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;

OR

- Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The subject must be expected to receive at least 4500 cGy to one of the following sites:

1. base of tongue

2. buccal/labial mucosa

3. epiglottis

4. floor of mouth

5. gingiva/alveolar ridge

6. hard palate

7. hypopharynx

8. larynx

9. lip

10. mandible

11. maxilla

12. maxillary sinus

13. nasal cavity

14. nasopharynx

15. neck

16. oral cavity

17. oral tongue

18. oropharynx

19. paranasal sinus/orbit

20. parotid gland

21. pharynx

22. retromolar trigone

23. soft palate

24. sublingual gland

25. submandibular gland

26. tonsil;

- At least 1 natural tooth remaining or expected to remain in the mouth after completion of the pre-RT dental extractions, if any;

- Willing to comply with all study procedures;

- Willing to participate for the duration of the study.

Exclusion Criteria:

- Receiving palliative RT;

- History of prior curative RT to the head and neck region to eradicate a malignancy;

- Incarcerated at time of screening;

- Anything that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
Locations
University of Connecticut Health Center - School of Dental Medicine
Farmington, Connecticut, United States
Status: Recruiting
Contact: Cynthia Rybczyk, RDH - 860-679-3918 - rybczyk@uchc.edu
Brigham and Women's Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Jennifer Brewer - 617-732-6813 - jbrewer6@partners.org
New York University - College of Dentistry
New York, New York, United States
Status: Recruiting
Contact: Makeda Culley - 212-998-9202 - makeda.culley@nyu.edu
Carolinas Medical Center - Dental Clinic
Charlotte, North Carolina, United States
Status: Recruiting
Contact: Maggie Tanner, RN, RDH - 704-355-0174 - maggie.tanner@carolinashealthcare.org
University of Pennsylvania - School of Dental Medicine
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Dan Vernau - 215-349-5409 - vernaud@mail.med.upenn.edu
Start Date
February 2014
Completion Date
May 2017
Sponsors
Carolinas Healthcare System
Source
Carolinas Healthcare System
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page