Observational Study of Dental Outcomes in Head and Neck Cancer Patients

Study Overview
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Brief Summary
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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
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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. Five hundred and seventy-five 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.

Official Title
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Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients

Conditions
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Head and Neck Cancer, Dental Disease, Xerostomia, Osteoradionecrosis

Participation Criteria
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Eligibility Criteria
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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: base of tongue buccal/labial mucosa epiglottis floor of mouth gingiva/alveolar ridge hard palate hypopharynx larynx lip mandible maxilla maxillary sinus nasal cavity nasopharynx neck oral cavity oral tongue oropharynx paranasal sinus/orbit parotid gland pharynx retromolar trigone soft palate sublingual gland submandibular gland 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients receiving head and neck RT<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth loss | The primary outcome measure is the two-year rate of tooth loss in patients who have received at least one session of external beam radiation therapy with curative intent for head and neck cancer. Tooth loss will be defined as a dental extraction that has been performed or recommended. Since dental extractions are often avoided in this population because of the increased risk of osteoradionecrosis (ORN), tooth loss will also include teeth having a dental procedure to avoid extraction of a tooth that would otherwise have been extracted if the individual had not received RT and teeth recommended for extraction that have not been treated. The following categories will constitute teeth that would otherwise be recommended for extraction: non-restorable because of fracture or extent of caries; amputated crown with root remaining; uncontrolled or persistent periodontal or odontogenic infection. | Two Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of exposed intraoral bone | Two year incidence of exposed intraoral bone, suggestive of ORN. This will be defined as exposed maxillary or mandibular bone with an avascular appearance in a quadrant that has received RT | Two Years | 
| Extraction complications | Incidence of post-extraction complications | Within 14 days following procedure | 
| Decayed, Missing or Filled Surfaces (DMFS) Index | Two year change in DMFS - Decayed, Missing or Filled Surfaces Index | Baseline, 24 months | 
| Periodontal Measures | Two year change in periodontal measures | Baseline, 24 months | 
| Stimulated Salivary Flow Rate | 18 month changes in stimulated whole salivary flow rates | Baseline, 18 months | 
| Trismus measure | Two year change in mouth opening in mm | Baseline, 24 months | 
| Topical fluoride use for caries prevention | Two year use of fluoride to prevent new caries | Baseline, 24 months | 
| Chronic Oral Mucositis Incidence | Two year chronic oral mucositis incidence | Baseline, 24 months | 
| Quality of Life after Radiation Therapy | Two year change in radiation therapy-specific quality of life measures | Baseline, 24 months | 
| Oral Cancer Pain Scale | Two year change in pain scores as measured with the University of California at San Francisco (UCSF) oral cancer pain scale | Baseline, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Cancer, Radiation Therapy