Head and Neck Cancer Clinical Trial
— ORARADOfficial title:
Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients
Verified date | August 2023 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
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 |
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 |
United States,
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
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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