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

• ClinicalTrials.gov Identifier: NCT02057510
• Recruitment Status: Active, not recruiting
• First Posted: February 7, 2014
• Last Update Posted: January 29, 2020
• Sponsor: Atrium Health
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR); University of Minnesota; UConn Health; University of Pennsylvania; Brigham and Women's Hospital; NYU Langone Health; University of North Carolina
• Information provided by (Responsible Party): Michael T. Brennan, Atrium Health

Study Description

Brief 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.

Condition or disease
Head and Neck Cancer; Dental Disease; Xerostomia; Osteoradionecrosis

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. 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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 575 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 24 Months
• Official Title: Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients
• Study Start Date: February 2014
• Estimated Primary Completion Date: November 2020
• Estimated Study Completion Date: November 2020

Groups and Cohorts

Group/Cohort
Patients receiving head and neck RT; No intervention

Outcome Measures

Primary Outcome Measures :

1. Tooth loss [ Time Frame: Two Years ]

   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.

Secondary Outcome Measures :

1. Incidence of exposed intraoral bone [ Time Frame: Two Years ]
   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
2. Extraction complications [ Time Frame: Within 14 days following procedure ]
   Incidence of post-extraction complications
3. Decayed, Missing or Filled Surfaces (DMFS) Index [ Time Frame: Baseline, 24 months ]
   Two year change in DMFS - Decayed, Missing or Filled Surfaces Index
4. Periodontal Measures [ Time Frame: Baseline, 24 months ]
   Two year change in periodontal measures
5. Stimulated Salivary Flow Rate [ Time Frame: Baseline, 18 months ]
   18 month changes in stimulated whole salivary flow rates
6. Trismus measure [ Time Frame: Baseline, 24 months ]
   Two year change in mouth opening in mm
7. Topical fluoride use for caries prevention [ Time Frame: Baseline, 24 months ]
   Two year use of fluoride to prevent new caries
8. Chronic Oral Mucositis Incidence [ Time Frame: Baseline, 24 months ]
   Two year chronic oral mucositis incidence
9. Quality of Life after Radiation Therapy [ Time Frame: Baseline, 24 months ]
   Two year change in radiation therapy-specific quality of life measures
10. Oral Cancer Pain Scale [ Time Frame: Baseline, 24 months ]
    Two year change in pain scores as measured with the University of California at San Francisco (UCSF) oral cancer pain scale

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Head and Neck Radiation Oncology patients

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.

Contacts and Locations

Locations

United States, Connecticut

University of Connecticut Health Center - School of Dental Medicine

Farmington, Connecticut, United States, 06030

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02120

United States, New York

New York University - College of Dentistry

New York, New York, United States, 10010

United States, North Carolina

University of North Carolina - School of Dentistry

Chapel Hill, North Carolina, United States, 27599

Carolinas Medical Center - Dental Clinic

Charlotte, North Carolina, United States, 28203

United States, Pennsylvania

University of Pennsylvania - School of Dental Medicine

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Atrium Health

National Institute of Dental and Craniofacial Research (NIDCR)

University of Minnesota

UConn Health

University of Pennsylvania

Brigham and Women's Hospital

NYU Langone Health

University of North Carolina

Investigators

• Study Chair: Michael T Brennan, DDS, MHS; Atrium Health
• Study Chair: Rajesh Lalla, DDS, PhD; University of Connecticut Health Center - School of Dental Medicine

More Information

Additional Information:

Publications of Results:

Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Mohammadi K, Long Simpson L, Voelker H, Hodges JS, Lalla RV. Dental disease before radiotherapy in patients with head and neck cancer: Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients. J Am Dent Assoc. 2017 Dec;148(12):868-877. doi: 10.1016/j.adaj.2017.09.011. Erratum in: J Am Dent Assoc. 2018 Feb;149(2):89.

Lalla RV, Treister N, Sollecito T, Schmidt B, Patton LL, Mohammadi K, Hodges JS, Brennan MT; OraRad Study Group. Oral complications at 6 months after radiation therapy for head and neck cancer. Oral Dis. 2017 Nov;23(8):1134-1143. doi: 10.1111/odi.12710. Epub 2017 Aug 3.

Lalla RV, Long-Simpson L, Hodges JS, Treister N, Sollecito T, Schmidt B, Patton LL, Brennan MT; OraRad Study Group. Clinical registry of dental outcomes in head and neck cancer patients (OraRad): rationale, methods, and recruitment considerations. BMC Oral Health. 2017 Feb 27;17(1):59. doi: 10.1186/s12903-017-0344-y.

• Responsible Party: Michael T. Brennan, Michael Brennan, DDS, MHS, Atrium Health
• ClinicalTrials.gov Identifier: NCT02057510
• Other Study ID Numbers: 12-040-E; 1U01DE022939-01 ( U.S. NIH Grant/Contract )
• First Posted: February 7, 2014
• Last Update Posted: January 29, 2020
• Last Verified: January 2020

Keywords provided by Michael T. Brennan, Atrium Health:

Head and Neck Cancer; Radiation Therapy

Additional relevant MeSH terms:

Head and Neck Neoplasms; Xerostomia; Stomatognathic Diseases; Osteoradionecrosis; Neoplasms by Site; Neoplasms; Salivary Gland Diseases; Mouth Diseases; Radiation Injuries; Wounds and Injuries