Observational Study of Dental Outcomes in Head and Neck Cancer Patients (ORARAD)

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Active, not recruiting

Conditions

Dental Disease
Osteoradionecrosis
Xerostomia
Head and Neck Cancer

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT02057510
12-040-E
1U01DE022939-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment

575 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

575 participants in 1 patient group

Patients receiving head and neck RT
Description:
No intervention

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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