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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
Phase
First received
Last updated
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
Health authority
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.

Study Design


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 allClick 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
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