Observational Study of Dental Outcomes in Head and Neck Cancer Patients

Head and Neck Cancer Clinical Trial

— ORARAD  

Official title:

Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02057510
• Other study ID #: 12-040-E
• Secondary ID: 1U01DE022939-01
• Status: Active, not recruiting
• Start date: February 2014
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 575
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Disease
• Head and Neck Cancer
• Head and Neck Neoplasms
• Osteoradionecrosis
• Stomatognathic Diseases
• Xerostomia

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of North Carolina - School of Dentistry	Chapel Hill	North Carolina
United States	Carolinas Medical Center - Dental Clinic	Charlotte	North Carolina
United States	University of Connecticut Health Center - School of Dental Medicine	Farmington	Connecticut
United States	New York University - College of Dentistry	New York	New York
United States	University of Pennsylvania - School of Dental Medicine	Philadelphia	Pennsylvania

Sponsors (8)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Brigham and Women's Hospital, National Institute of Dental and Craniofacial Research (NIDCR), NYU Langone Health, UConn Health, University of Minnesota, University of North Carolina, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (15)

Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Elting LS, Helgeson ES, Lalla RV. Dental Caries Postradiotherapy in Head and Neck Cancer. JDR Clin Trans Res. 2023 Jul;8(3):234-243. doi: 10.1177/23800844221086563. Epub 2022 Apr 11. — View Citation

Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Elting LS, Hodges JS, Lalla RV. Tooth Failure Post-Radiotherapy in Head and Neck Cancer: Primary Report of the Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (OraR — View Citation

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 Canc — View Citation

Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Yang Y, Lin A, Elting LS, Hodges JS, Lalla RV. Epidemiologic factors in patients with advanced head and neck cancer treated with radiation therapy. Head Neck. 2021 Jan;43(1):164-172. doi: 10.10 — View Citation

Lalla RV, Hodges JS, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Brennan MT. Tooth-level predictors of tooth loss and exposed bone after radiation therapy for head and neck cancer. J Am Dent Assoc. 2023 Jun;154(6):519-528.e4. doi: 10.1016/j.a — View Citation

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 Ora — View Citation

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. E — View Citation

Lalla RV, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Helgeson ES, Lin A, Rybczyk C, Dowsett R, Hegde U, Boyd TS, Duplinsky TG, Brennan MT. Radiation therapy for head and neck cancer leads to gingival recession associated with dental caries. Oral Su — View Citation

Lin A, Helgeson ES, Treister NS, Schmidt BL, Patton LL, Elting LS, Lalla RV, Brennan MT, Sollecito TP. The impact of head and neck radiotherapy on salivary flow and quality of life: Results of the ORARAD study. Oral Oncol. 2022 Apr;127:105783. doi: 10.101 — View Citation

Mougeot JC, Stevens CB, Almon KG, Paster BJ, Lalla RV, Brennan MT, Mougeot FB. Caries-associated oral microbiome in head and neck cancer radiation patients: a longitudinal study. J Oral Microbiol. 2019 Mar 8;11(1):1586421. doi: 10.1080/20002297.2019.15864 — View Citation

Patton LL, Helgeson ES, Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Lin A, Chera BS, Lalla RV. Oral health-related quality of life after radiation therapy for head and neck cancer: the OraRad study. Support Care Cancer. 2023 Apr 20;31(5):286. doi: — View Citation

Talevi V, Wen J, Lalla RV, Brennan MT, Mougeot FB, Mougeot JC. Identification of single nucleotide pleomorphisms associated with periodontal disease in head and neck cancer irradiation patients by exome sequencing. Oral Surg Oral Med Oral Pathol Oral Radi — View Citation

Threet EJ, Napenas JJ, Petersen C, Mitchell R, Long-Simpson L, Shadick R, Valentino KC, Rybczyk CA, Blake JA, Brown MC, Aidoo R, Helgeson ES, Lalla RV, Brennan MT. Survey of experiences and barriers to dental care post-head and neck cancer in OraRad study — View Citation

Treister NS, Brennan MT, Sollecito TP, Schmidt BL, Patton LL, Mitchell R, Haddad RI, Tishler RB, Lin A, Shadick R, Hodges JS, Lalla RV. Exposed bone in patients with head and neck cancer treated with radiation therapy: An analysis of the Observational Stu — View Citation

Ward MC, Carpenter MD, Noll J, Carrizosa D, Moeller BJ, Helgeson ES, Lalla RV, Brennan MT. Oncologists' Perspective on Dental Care Around the Treatment of Head and Neck Cancer: A Pattern of Practice Survey. JCO Oncol Pract. 2022 Jan;18(1):e28-e35. doi: 10 — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Extraction complications	Incidence of post-extraction complications	Within 14 days following procedure
Secondary	Decayed, Missing or Filled Surfaces (DMFS) Index	Two year change in DMFS - Decayed, Missing or Filled Surfaces Index	Baseline, 24 months
Secondary	Periodontal Measures	Two year change in periodontal measures	Baseline, 24 months
Secondary	Stimulated Salivary Flow Rate	18 month changes in stimulated whole salivary flow rates	Baseline, 18 months
Secondary	Trismus measure	Two year change in mouth opening in mm	Baseline, 24 months
Secondary	Topical fluoride use for caries prevention	Two year use of fluoride to prevent new caries	Baseline, 24 months
Secondary	Chronic Oral Mucositis Incidence	Two year chronic oral mucositis incidence	Baseline, 24 months
Secondary	Quality of Life after Radiation Therapy	Two year change in radiation therapy-specific quality of life measures	Baseline, 24 months
Secondary	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